Randomised Control Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2010-2010

ABSTRACT

Investigators hypothesize that virtual reality based training offers an additional learning benefit over standard training (using cadaveric dissection and human volunteers) in preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus Blockade (USgABPB) in the clinical setting. Investigators hope that this body of work will aid the development of a visuo-haptic simulator used to improved training of doctors in performing USgABPB. Ultimately any patient having this procedure carried out in the future should benefit. In particular it will avoid the need for novice trainees to practice new techniques on patients. Detailed Description Ultrasound guided axillary brachial plexus blockade (USgABPB) is a commonly performed medical procedure which enables the performance of surgery on the upper limb without general anaesthesia. Its competent performance entails complex, simultaneous interactions between three processes. These are active management of the patient, acquisition and interpretation of ultrasound images, and the placement a needle tip close to specific nerves to facilitate deposition of local anaesthetic. Currently, the procedure is taught using two-dimensional drawings, cadaveric specimens, videos, 3D animations, live demonstrations, and/or supervised clinical practice. Simulated practice, using tofu-based or animal models, have been used to bridge the gap from knowledge to clinical performance. Training in medical procedural skills is currently undergoing important change. Factors including altered patient expectations and the European Working Time Directive (2000/34/EC amending Directive 93/104/EC) limit the number of clinical learning opportunities available to trainees. These changes are likely to decrease particularly the number of opportunities for trainees to learn and practice procedural skills in a clinical setting. The traditional Halstedian apprenticeship model of medical training is being challenged. In this model, training is associated with progressively less supervision as part of progressive independence. "See one, do one" is no longer an appropriate method for teaching procedural skills because patients are necessarily exposed to inexperienced practitioners. This model requires a large investment of time by both trainer and trainee in the clinical environment. Its application decreases the efficiency of operating room activity. These circumstances pose medical trainers and training bodies with a dilemma, a decrease in the number of individual opportunities implies that the total duration of training should increase or a lesser level of competence accepted at completion of training Simulation has been used widely for training in and assessment of medical procedural skills. Applied to essential anaesthetic skills, simulation may be more efficient than the apprenticeship approach. This may offer a partial solution to the problem of limited clinical learning opportunities for USgPNB. Simulated practice with formative feedback has been shown to be of benefit in the rapid acquisition of basic ultrasound skills by inexperienced clinicians. Ultimately, the purpose of simulated practice of medical procedures is to enhance clinical performance. One proven important role for simulation is to prepare novice clinicians to bridge the gap between acquiring knowledge and initial clinical performance. Significantly, the Food and Drug Administration (FDA) has recently mandated that clinicians who perform carotid stenting using a particular stent should train to a defined level of proficiency on a simulator before they perform the procedure on a patient. With institutional ethical approval and having obtained written informed consent from participants (patients and anaesthetists) 20 College of Anaesthetists (RCSI) affiliated trainees who have no experience of performing ultrasound guided regional anaesthesia will be recruited. Participating anaesthetists will provide baseline personal data including previous experience with peripheral nerve blockade and simulators, using a web-based collection facility (www.surveymonkey.com or similar). They will perform baseline psychomotor tests prior to beginning training. Baseline visuo-spatial ability will be assessed using the card rotation, cube comparison, and map planning tests (Educational Testing Service) or similar. Psychomotor ability will be assessed using a grooved pegboard (Lafayette Instruments, Lafayette, IN) or similar. All participating anaesthetists will receive standardized two hour didactic training encompassing relevant anatomy, ultrasound (physics, function and interpretation), pharmacology of relevant agents, indications/ contraindications of the block and complications of the procedure. Participants will be taught to perform USgABPB using a technique as described in Appendix IV and V of 'The American Society of Regional Anesthesia and Pain Medicine and the European Society of Regional Anaesthesia and Pain Therapy Joint Committee Recommendations for Education and Training in Ultrasound-Guided Regional Anesthesia'. This technique uses a transverse (or short-axis) view, on ultrasound imaging, of the axillary brachial plexus and axillary blood vessels. The needle is inserted in a sterile fashion using an 'in-plane' approach, that is, the needle shaft and tip will remain visible on ultrasound view throughout it course towards the relevant nerves. Following this initial period of common training subjects will be randomly allocated (using computer generated random numbers) to one of two groups of equal size for additional training which will occur in parallel over a two hour period, namely a simulator trained group (SG) or a control group (CG). Following the educational intervention all subjects will be asked to give written feedback on the content and delivery of the session. Traditional training TG subjects will be offered multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts). All ultrasound examinations performed on volunteers or during the clinical performance on patients will use a Sonosite M Turbo (or similar device) with a 7-12 MHz 38mm linear probe. This training session will last two hours. Simulator training In addition to traditional training the SG group will participate in a period of simulator based training. Following initial familiarization with the simulator SG participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed feedback by an expert and offered the opportunity for repetitive, deliberate practice. The simulator, which SG participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. The model of the arm will be informed using MRI or ultrasound supervolume DICOM datasets. This training session will last two hours. Assessment Within two weeks of the educational intervention all participants' first clinical performance of an ultrasound guided nerve block, specifically an ultrasound guided axillary brachial plexus blockade, will be video recorded for subsequent analysis by two experts in UGRA. Patients involved will require anaesthesia for forearm/wrist/hand surgery where USgABPB would ordinarily be offered as standard care. Subsequent care of the patient may include general anaesthesia, as clinically indicated. Intravenous sedation will be offered and administered as clinically indicated (Midazolam up to a maximum of 0.05mg/kg). Subjects will perform the procedure, using an in-plane approach and short-axis view (see above), in the presence of a supervising trainer, blinded to training group, who is available to intervene if required, for patient safety, or requested by the subjects themselves. Patients involved will also be blinded to subject allocation. Using a video recording device Sony Handycam HDR-XR520VE, or similar, the performance of a clinician indicated USgABPB for a scheduled operation on patients will be recorded. The video-taping will target primarily the anaesthetist performing the clinically indicated ultrasound guided regional anaesthetic technique in the usual fashion at Cork University Hospital. The recording will proceed in a manner aimed to conceal the identity of the patient and maintain confidentiality. All efforts will be taken to ensure the recording will not include images of the patients face. For the purpose of blinding, a similar effort will be made conceal the identity of the anaesthetists performing the block by avoiding shots of their faces. The recording will include a pan shot of the setup of the room the block will take place in. This will indicate the location of the patient, the ultrasound machine, the trolley with the sterile equipment required, the assistant, the monitor, the emergency drugs, and the anaesthetist performing the block. Before commencing the block the camera will be fixed in position focusing on the axilla, with needle insertion site, ultrasound probe and the movements of the anaesthetist's hands recorded. The acquired ultrasound image will be recorded concurrently. After expert assessment of trainee performance and completion of the dataset all recorded video will be destroyed. For the purpose of the study the subjects will be give some specific directions. 1. Position the patient and equipment appropriately. 2. They will be asked to perform a pre-procedure ultrasonic survey of the relevant area, specifically identifying the four relevant nerves (musculocutaneous, radial, median, and ulnar). 3. Perform a sterile four nerve ultrasound-guided axillary brachial plexus block, utilizing a single skin entry point (where possible), short axis view of the brachial plexus, and needle in-plane approach. 4. They will be asked to demonstrate the effectiveness of the blockade. Following the recorded performance of the procedure the subjects will be asked to complete a written questionnaire indicating their confidence in performing the procedure and their perception of the influence of external stressors (including the presence of a camera). More... »

URL

https://clinicaltrials.gov/show/NCT01965314

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/2746", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "Investigators hypothesize that virtual reality based training offers an additional learning benefit over standard training (using cadaveric dissection and human volunteers) in preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus Blockade (USgABPB) in the clinical setting. Investigators hope that this body of work will aid the development of a visuo-haptic simulator used to improved training of doctors in performing USgABPB. Ultimately any patient having this procedure carried out in the future should benefit. In particular it will avoid the need for novice trainees to practice new techniques on patients.\n\nDetailed Description\nUltrasound guided axillary brachial plexus blockade (USgABPB) is a commonly performed medical procedure which enables the performance of surgery on the upper limb without general anaesthesia. Its competent performance entails complex, simultaneous interactions between three processes. These are active management of the patient, acquisition and interpretation of ultrasound images, and the placement a needle tip close to specific nerves to facilitate deposition of local anaesthetic. Currently, the procedure is taught using two-dimensional drawings, cadaveric specimens, videos, 3D animations, live demonstrations, and/or supervised clinical practice. Simulated practice, using tofu-based or animal models, have been used to bridge the gap from knowledge to clinical performance. Training in medical procedural skills is currently undergoing important change. Factors including altered patient expectations and the European Working Time Directive (2000/34/EC amending Directive 93/104/EC) limit the number of clinical learning opportunities available to trainees. These changes are likely to decrease particularly the number of opportunities for trainees to learn and practice procedural skills in a clinical setting. The traditional Halstedian apprenticeship model of medical training is being challenged. In this model, training is associated with progressively less supervision as part of progressive independence. \"See one, do one\" is no longer an appropriate method for teaching procedural skills because patients are necessarily exposed to inexperienced practitioners. This model requires a large investment of time by both trainer and trainee in the clinical environment. Its application decreases the efficiency of operating room activity. These circumstances pose medical trainers and training bodies with a dilemma, a decrease in the number of individual opportunities implies that the total duration of training should increase or a lesser level of competence accepted at completion of training Simulation has been used widely for training in and assessment of medical procedural skills. Applied to essential anaesthetic skills, simulation may be more efficient than the apprenticeship approach. This may offer a partial solution to the problem of limited clinical learning opportunities for USgPNB. Simulated practice with formative feedback has been shown to be of benefit in the rapid acquisition of basic ultrasound skills by inexperienced clinicians. Ultimately, the purpose of simulated practice of medical procedures is to enhance clinical performance. One proven important role for simulation is to prepare novice clinicians to bridge the gap between acquiring knowledge and initial clinical performance. Significantly, the Food and Drug Administration (FDA) has recently mandated that clinicians who perform carotid stenting using a particular stent should train to a defined level of proficiency on a simulator before they perform the procedure on a patient. With institutional ethical approval and having obtained written informed consent from participants (patients and anaesthetists) 20 College of Anaesthetists (RCSI) affiliated trainees who have no experience of performing ultrasound guided regional anaesthesia will be recruited. Participating anaesthetists will provide baseline personal data including previous experience with peripheral nerve blockade and simulators, using a web-based collection facility (www.surveymonkey.com or similar). They will perform baseline psychomotor tests prior to beginning training. Baseline visuo-spatial ability will be assessed using the card rotation, cube comparison, and map planning tests (Educational Testing Service) or similar. Psychomotor ability will be assessed using a grooved pegboard (Lafayette Instruments, Lafayette, IN) or similar. All participating anaesthetists will receive standardized two hour didactic training encompassing relevant anatomy, ultrasound (physics, function and interpretation), pharmacology of relevant agents, indications/ contraindications of the block and complications of the procedure. Participants will be taught to perform USgABPB using a technique as described in Appendix IV and V of 'The American Society of Regional Anesthesia and Pain Medicine and the European Society of Regional Anaesthesia and Pain Therapy Joint Committee Recommendations for Education and Training in Ultrasound-Guided Regional Anesthesia'. This technique uses a transverse (or short-axis) view, on ultrasound imaging, of the axillary brachial plexus and axillary blood vessels. The needle is inserted in a sterile fashion using an 'in-plane' approach, that is, the needle shaft and tip will remain visible on ultrasound view throughout it course towards the relevant nerves. Following this initial period of common training subjects will be randomly allocated (using computer generated random numbers) to one of two groups of equal size for additional training which will occur in parallel over a two hour period, namely a simulator trained group (SG) or a control group (CG). Following the educational intervention all subjects will be asked to give written feedback on the content and delivery of the session. Traditional training TG subjects will be offered multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts). All ultrasound examinations performed on volunteers or during the clinical performance on patients will use a Sonosite M Turbo (or similar device) with a 7-12 MHz 38mm linear probe. This training session will last two hours. Simulator training In addition to traditional training the SG group will participate in a period of simulator based training. Following initial familiarization with the simulator SG participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed feedback by an expert and offered the opportunity for repetitive, deliberate practice. The simulator, which SG participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. The model of the arm will be informed using MRI or ultrasound supervolume DICOM datasets. This training session will last two hours. Assessment Within two weeks of the educational intervention all participants' first clinical performance of an ultrasound guided nerve block, specifically an ultrasound guided axillary brachial plexus blockade, will be video recorded for subsequent analysis by two experts in UGRA. Patients involved will require anaesthesia for forearm/wrist/hand surgery where USgABPB would ordinarily be offered as standard care. Subsequent care of the patient may include general anaesthesia, as clinically indicated. Intravenous sedation will be offered and administered as clinically indicated (Midazolam up to a maximum of 0.05mg/kg). Subjects will perform the procedure, using an in-plane approach and short-axis view (see above), in the presence of a supervising trainer, blinded to training group, who is available to intervene if required, for patient safety, or requested by the subjects themselves. Patients involved will also be blinded to subject allocation. Using a video recording device Sony Handycam HDR-XR520VE, or similar, the performance of a clinician indicated USgABPB for a scheduled operation on patients will be recorded. The video-taping will target primarily the anaesthetist performing the clinically indicated ultrasound guided regional anaesthetic technique in the usual fashion at Cork University Hospital. The recording will proceed in a manner aimed to conceal the identity of the patient and maintain confidentiality. All efforts will be taken to ensure the recording will not include images of the patients face. For the purpose of blinding, a similar effort will be made conceal the identity of the anaesthetists performing the block by avoiding shots of their faces. The recording will include a pan shot of the setup of the room the block will take place in. This will indicate the location of the patient, the ultrasound machine, the trolley with the sterile equipment required, the assistant, the monitor, the emergency drugs, and the anaesthetist performing the block. Before commencing the block the camera will be fixed in position focusing on the axilla, with needle insertion site, ultrasound probe and the movements of the anaesthetist's hands recorded. The acquired ultrasound image will be recorded concurrently. After expert assessment of trainee performance and completion of the dataset all recorded video will be destroyed. For the purpose of the study the subjects will be give some specific directions. 1. Position the patient and equipment appropriately. 2. They will be asked to perform a pre-procedure ultrasonic survey of the relevant area, specifically identifying the four relevant nerves (musculocutaneous, radial, median, and ulnar). 3. Perform a sterile four nerve ultrasound-guided axillary brachial plexus block, utilizing a single skin entry point (where possible), short axis view of the brachial plexus, and needle in-plane approach. 4. They will be asked to demonstrate the effectiveness of the blockade. Following the recorded performance of the procedure the subjects will be asked to complete a written questionnaire indicating their confidence in performing the procedure and their perception of the influence of external stressors (including the presence of a camera).", 
    "endDate": "2010-11-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT01965314", 
    "keywords": [
      "control trial", 
      "Determine", 
      "simulation", 
      "ultrasound", 
      "blockade", 
      "clinical setting", 
      "virtual reality", 
      "benefit", 
      "standard training", 
      "dissection", 
      "healthy volunteer", 
      "anaesthetist", 
      "investigator hope", 
      "body", 
      "development", 
      "simulator", 
      "improved training", 
      "doctor", 
      "patient", 
      "method", 
      "trainee", 
      "practice", 
      "technique", 
      "medical procedure", 
      "General Surgery", 
      "Upper Extremity", 
      "general anesthesia", 
      "complex", 
      "simultaneous interaction", 
      "active management", 
      "acquisition", 
      "interpretation", 
      "ultrasound image", 
      "placement", 
      "needle tip", 
      "nerve", 
      "deposition", 
      "drawing", 
      "cadaveric specimen", 
      "video", 
      "animation", 
      "live demonstration", 
      "clinical practice", 
      "animal model", 
      "gap", 
      "clinical performance", 
      "skill", 
      "important change", 
      "patient expectation", 
      "working", 
      "directive", 
      "decrease", 
      "apprenticeship", 
      "medical training", 
      "independence", 
      "appropriate method", 
      "teaching", 
      "practitioner", 
      "large investment", 
      "clinical environment", 
      "efficiency", 
      "room", 
      "circumstance", 
      "trainer", 
      "dilemma", 
      "individual", 
      "total duration", 
      "Mental Competency", 
      "completion", 
      "training simulation", 
      "assessment", 
      "anesthetic", 
      "partial solution", 
      "formative feedback", 
      "rapid acquisition", 
      "clinician", 
      "important role", 
      "United State Food and Drug Administration", 
      "stenting", 
      "stent", 
      "train", 
      "defined level", 
      "proficiency", 
      "ethical approval", 
      "written informed consent", 
      "Conduction Anesthesia", 
      "personal data", 
      "peripheral nerve", 
      "collection", 
      "psychomotor", 
      "spatial ability", 
      "rotation", 
      "comparison", 
      "map", 
      "service", 
      "instrument", 
      "Lafayette", 
      "IN", 
      "didactic training", 
      "anatomy", 
      "physic", 
      "pharmacology", 
      "agent", 
      "contraindication", 
      "complication", 
      "Appendix", 
      "American society", 
      "pain medicine", 
      "European society", 
      "pain therapy", 
      "Education and Training", 
      "transverse", 
      "axis", 
      "Ultrasonography", 
      "plexus", 
      "blood vessel", 
      "needle", 
      "fashion", 
      "in-plane", 
      "tip", 
      "initial period", 
      "random number", 
      "equal size", 
      "additional training", 
      "parallel", 
      "hour period", 
      "control group", 
      "educational intervention", 
      "feedback", 
      "content", 
      "delivery", 
      "session", 
      "traditional training", 
      "demonstration", 
      "trained individual", 
      "sample", 
      "relevant area", 
      "volunteer", 
      "expert", 
      "needle insertion", 
      "ultrasound guidance", 
      "tissue phantom", 
      "Turkey", 
      "ultrasound examination", 
      "turbo", 
      "similar device", 
      "probe", 
      "training session", 
      "period", 
      "familiarization", 
      "group participant", 
      "relevant structure", 
      "arm", 
      "insert", 
      "virtual environment", 
      "target structure", 
      "phantom", 
      "workbench", 
      "specific task", 
      "MRI", 
      "subsequent analysis", 
      "anesthesia", 
      "standard care", 
      "care", 
      "sedation", 
      "midazolam", 
      "maximum", 
      "supervising", 
      "training group", 
      "patient safety", 
      "allocation", 
      "recording device", 
      "HDR", 
      "operation", 
      "target", 
      "University Hospital", 
      "recording", 
      "identity", 
      "confidentiality", 
      "blinding", 
      "similar effort", 
      "shot", 
      "setup", 
      "location", 
      "ultrasound machine", 
      "trolley", 
      "assistant", 
      "emergency", 
      "camera", 
      "axilla", 
      "ultrasound probe", 
      "movement", 
      "hand", 
      "expert assessment", 
      "Dataset", 
      "specific direction", 
      "Equipment and Supply", 
      "Perform", 
      "entry point", 
      "effectiveness", 
      "written questionnaire", 
      "confidence", 
      "perception", 
      "stressor"
    ], 
    "name": "Randomised Control Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus Blockade in a Clinical Setting", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT01965314"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:25", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00015.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.411916.a", 
        "type": "Organization"
      }
    ], 
    "startDate": "2010-07-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "sg:pub.10.1186/1471-2253-14-110", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053695629", 
          "https://doi.org/10.1186/1471-2253-14-110"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT01965314"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT01965314'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT01965314'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT01965314'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT01965314'


 

This table displays all metadata directly associated to this object as RDF triples.

230 TRIPLES      16 PREDICATES      221 URIs      213 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT01965314 schema:about anzsrc-for:2746
2 anzsrc-for:3053
3 schema:description Investigators hypothesize that virtual reality based training offers an additional learning benefit over standard training (using cadaveric dissection and human volunteers) in preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus Blockade (USgABPB) in the clinical setting. Investigators hope that this body of work will aid the development of a visuo-haptic simulator used to improved training of doctors in performing USgABPB. Ultimately any patient having this procedure carried out in the future should benefit. In particular it will avoid the need for novice trainees to practice new techniques on patients. Detailed Description Ultrasound guided axillary brachial plexus blockade (USgABPB) is a commonly performed medical procedure which enables the performance of surgery on the upper limb without general anaesthesia. Its competent performance entails complex, simultaneous interactions between three processes. These are active management of the patient, acquisition and interpretation of ultrasound images, and the placement a needle tip close to specific nerves to facilitate deposition of local anaesthetic. Currently, the procedure is taught using two-dimensional drawings, cadaveric specimens, videos, 3D animations, live demonstrations, and/or supervised clinical practice. Simulated practice, using tofu-based or animal models, have been used to bridge the gap from knowledge to clinical performance. Training in medical procedural skills is currently undergoing important change. Factors including altered patient expectations and the European Working Time Directive (2000/34/EC amending Directive 93/104/EC) limit the number of clinical learning opportunities available to trainees. These changes are likely to decrease particularly the number of opportunities for trainees to learn and practice procedural skills in a clinical setting. The traditional Halstedian apprenticeship model of medical training is being challenged. In this model, training is associated with progressively less supervision as part of progressive independence. "See one, do one" is no longer an appropriate method for teaching procedural skills because patients are necessarily exposed to inexperienced practitioners. This model requires a large investment of time by both trainer and trainee in the clinical environment. Its application decreases the efficiency of operating room activity. These circumstances pose medical trainers and training bodies with a dilemma, a decrease in the number of individual opportunities implies that the total duration of training should increase or a lesser level of competence accepted at completion of training Simulation has been used widely for training in and assessment of medical procedural skills. Applied to essential anaesthetic skills, simulation may be more efficient than the apprenticeship approach. This may offer a partial solution to the problem of limited clinical learning opportunities for USgPNB. Simulated practice with formative feedback has been shown to be of benefit in the rapid acquisition of basic ultrasound skills by inexperienced clinicians. Ultimately, the purpose of simulated practice of medical procedures is to enhance clinical performance. One proven important role for simulation is to prepare novice clinicians to bridge the gap between acquiring knowledge and initial clinical performance. Significantly, the Food and Drug Administration (FDA) has recently mandated that clinicians who perform carotid stenting using a particular stent should train to a defined level of proficiency on a simulator before they perform the procedure on a patient. With institutional ethical approval and having obtained written informed consent from participants (patients and anaesthetists) 20 College of Anaesthetists (RCSI) affiliated trainees who have no experience of performing ultrasound guided regional anaesthesia will be recruited. Participating anaesthetists will provide baseline personal data including previous experience with peripheral nerve blockade and simulators, using a web-based collection facility (www.surveymonkey.com or similar). They will perform baseline psychomotor tests prior to beginning training. Baseline visuo-spatial ability will be assessed using the card rotation, cube comparison, and map planning tests (Educational Testing Service) or similar. Psychomotor ability will be assessed using a grooved pegboard (Lafayette Instruments, Lafayette, IN) or similar. All participating anaesthetists will receive standardized two hour didactic training encompassing relevant anatomy, ultrasound (physics, function and interpretation), pharmacology of relevant agents, indications/ contraindications of the block and complications of the procedure. Participants will be taught to perform USgABPB using a technique as described in Appendix IV and V of 'The American Society of Regional Anesthesia and Pain Medicine and the European Society of Regional Anaesthesia and Pain Therapy Joint Committee Recommendations for Education and Training in Ultrasound-Guided Regional Anesthesia'. This technique uses a transverse (or short-axis) view, on ultrasound imaging, of the axillary brachial plexus and axillary blood vessels. The needle is inserted in a sterile fashion using an 'in-plane' approach, that is, the needle shaft and tip will remain visible on ultrasound view throughout it course towards the relevant nerves. Following this initial period of common training subjects will be randomly allocated (using computer generated random numbers) to one of two groups of equal size for additional training which will occur in parallel over a two hour period, namely a simulator trained group (SG) or a control group (CG). Following the educational intervention all subjects will be asked to give written feedback on the content and delivery of the session. Traditional training TG subjects will be offered multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts). All ultrasound examinations performed on volunteers or during the clinical performance on patients will use a Sonosite M Turbo (or similar device) with a 7-12 MHz 38mm linear probe. This training session will last two hours. Simulator training In addition to traditional training the SG group will participate in a period of simulator based training. Following initial familiarization with the simulator SG participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed feedback by an expert and offered the opportunity for repetitive, deliberate practice. The simulator, which SG participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. The model of the arm will be informed using MRI or ultrasound supervolume DICOM datasets. This training session will last two hours. Assessment Within two weeks of the educational intervention all participants' first clinical performance of an ultrasound guided nerve block, specifically an ultrasound guided axillary brachial plexus blockade, will be video recorded for subsequent analysis by two experts in UGRA. Patients involved will require anaesthesia for forearm/wrist/hand surgery where USgABPB would ordinarily be offered as standard care. Subsequent care of the patient may include general anaesthesia, as clinically indicated. Intravenous sedation will be offered and administered as clinically indicated (Midazolam up to a maximum of 0.05mg/kg). Subjects will perform the procedure, using an in-plane approach and short-axis view (see above), in the presence of a supervising trainer, blinded to training group, who is available to intervene if required, for patient safety, or requested by the subjects themselves. Patients involved will also be blinded to subject allocation. Using a video recording device Sony Handycam HDR-XR520VE, or similar, the performance of a clinician indicated USgABPB for a scheduled operation on patients will be recorded. The video-taping will target primarily the anaesthetist performing the clinically indicated ultrasound guided regional anaesthetic technique in the usual fashion at Cork University Hospital. The recording will proceed in a manner aimed to conceal the identity of the patient and maintain confidentiality. All efforts will be taken to ensure the recording will not include images of the patients face. For the purpose of blinding, a similar effort will be made conceal the identity of the anaesthetists performing the block by avoiding shots of their faces. The recording will include a pan shot of the setup of the room the block will take place in. This will indicate the location of the patient, the ultrasound machine, the trolley with the sterile equipment required, the assistant, the monitor, the emergency drugs, and the anaesthetist performing the block. Before commencing the block the camera will be fixed in position focusing on the axilla, with needle insertion site, ultrasound probe and the movements of the anaesthetist's hands recorded. The acquired ultrasound image will be recorded concurrently. After expert assessment of trainee performance and completion of the dataset all recorded video will be destroyed. For the purpose of the study the subjects will be give some specific directions. 1. Position the patient and equipment appropriately. 2. They will be asked to perform a pre-procedure ultrasonic survey of the relevant area, specifically identifying the four relevant nerves (musculocutaneous, radial, median, and ulnar). 3. Perform a sterile four nerve ultrasound-guided axillary brachial plexus block, utilizing a single skin entry point (where possible), short axis view of the brachial plexus, and needle in-plane approach. 4. They will be asked to demonstrate the effectiveness of the blockade. Following the recorded performance of the procedure the subjects will be asked to complete a written questionnaire indicating their confidence in performing the procedure and their perception of the influence of external stressors (including the presence of a camera).
4 schema:endDate 2010-11-01T00:00:00Z
5 schema:keywords American society
6 Appendix
7 Conduction Anesthesia
8 Dataset
9 Determine
10 Education and Training
11 Equipment and Supply
12 European society
13 General Surgery
14 HDR
15 IN
16 Lafayette
17 MRI
18 Mental Competency
19 Perform
20 Turkey
21 Ultrasonography
22 United State Food and Drug Administration
23 University Hospital
24 Upper Extremity
25 acquisition
26 active management
27 additional training
28 agent
29 allocation
30 anaesthetist
31 anatomy
32 anesthesia
33 anesthetic
34 animal model
35 animation
36 apprenticeship
37 appropriate method
38 arm
39 assessment
40 assistant
41 axilla
42 axis
43 benefit
44 blinding
45 blockade
46 blood vessel
47 body
48 cadaveric specimen
49 camera
50 care
51 circumstance
52 clinical environment
53 clinical performance
54 clinical practice
55 clinical setting
56 clinician
57 collection
58 comparison
59 completion
60 complex
61 complication
62 confidence
63 confidentiality
64 content
65 contraindication
66 control group
67 control trial
68 decrease
69 defined level
70 delivery
71 demonstration
72 deposition
73 development
74 didactic training
75 dilemma
76 directive
77 dissection
78 doctor
79 drawing
80 educational intervention
81 effectiveness
82 efficiency
83 emergency
84 entry point
85 equal size
86 ethical approval
87 expert
88 expert assessment
89 familiarization
90 fashion
91 feedback
92 formative feedback
93 gap
94 general anesthesia
95 group participant
96 hand
97 healthy volunteer
98 hour period
99 identity
100 important change
101 important role
102 improved training
103 in-plane
104 independence
105 individual
106 initial period
107 insert
108 instrument
109 interpretation
110 investigator hope
111 large investment
112 live demonstration
113 location
114 map
115 maximum
116 medical procedure
117 medical training
118 method
119 midazolam
120 movement
121 needle
122 needle insertion
123 needle tip
124 nerve
125 operation
126 pain medicine
127 pain therapy
128 parallel
129 partial solution
130 patient
131 patient expectation
132 patient safety
133 perception
134 period
135 peripheral nerve
136 personal data
137 phantom
138 pharmacology
139 physic
140 placement
141 plexus
142 practice
143 practitioner
144 probe
145 proficiency
146 psychomotor
147 random number
148 rapid acquisition
149 recording
150 recording device
151 relevant area
152 relevant structure
153 room
154 rotation
155 sample
156 sedation
157 service
158 session
159 setup
160 shot
161 similar device
162 similar effort
163 simulation
164 simulator
165 simultaneous interaction
166 skill
167 spatial ability
168 specific direction
169 specific task
170 standard care
171 standard training
172 stent
173 stenting
174 stressor
175 subsequent analysis
176 supervising
177 target
178 target structure
179 teaching
180 technique
181 tip
182 tissue phantom
183 total duration
184 traditional training
185 train
186 trained individual
187 trainee
188 trainer
189 training group
190 training session
191 training simulation
192 transverse
193 trolley
194 turbo
195 ultrasound
196 ultrasound examination
197 ultrasound guidance
198 ultrasound image
199 ultrasound machine
200 ultrasound probe
201 video
202 virtual environment
203 virtual reality
204 volunteer
205 workbench
206 working
207 written informed consent
208 written questionnaire
209 schema:name Randomised Control Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus Blockade in a Clinical Setting
210 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT01965314
211 schema:sdDatePublished 2019-03-07T15:25
212 schema:sdLicense https://scigraph.springernature.com/explorer/license/
213 schema:sdPublisher Ned9b1814065f46038235bea6bdeba7fd
214 schema:sponsor https://www.grid.ac/institutes/grid.411916.a
215 schema:startDate 2010-07-01T00:00:00Z
216 schema:subjectOf sg:pub.10.1186/1471-2253-14-110
217 schema:url https://clinicaltrials.gov/show/NCT01965314
218 sgo:license sg:explorer/license/
219 sgo:sdDataset clinical_trials
220 rdf:type schema:MedicalStudy
221 Ned9b1814065f46038235bea6bdeba7fd schema:name Springer Nature - SN SciGraph project
222 rdf:type schema:Organization
223 anzsrc-for:2746 schema:inDefinedTermSet anzsrc-for:
224 rdf:type schema:DefinedTerm
225 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
226 rdf:type schema:DefinedTerm
227 sg:pub.10.1186/1471-2253-14-110 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053695629
228 https://doi.org/10.1186/1471-2253-14-110
229 rdf:type schema:CreativeWork
230 https://www.grid.ac/institutes/grid.411916.a schema:Organization
 




Preview window. Press ESC to close (or click here)


...