Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial View Full Text


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Article Info

DATE

2019-01-17

AUTHORS

Douglas Evans, Deborah Shure, Linda Clark, Gerard J. Criner, Martin Dres, Marcelo Gama de Abreu, Franco Laghi, David McDonagh, Basil Petrof, Teresa Nelson, Thomas Similowski

ABSTRACT

BackgroundMechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality.Methods and analysisThis paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization.DiscussionThis study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP.Trial registrationClinicalTrials.gov, NCT03096639. Registered on 30 March 2017. More... »

PAGES

60

References to SciGraph publications

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  • 2010-11-15. Nitroglycerin can facilitate weaning of difficult-to-wean chronic obstructive pulmonary disease patients: a prospective interventional non-randomized study in CRITICAL CARE
  • 2017-09-15. Critical illness-associated diaphragm weakness in INTENSIVE CARE MEDICINE
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  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    20

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-018-3171-9

    DOI

    http://dx.doi.org/10.1186/s13063-018-3171-9

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1111501457

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30654837


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    374 grid-institutes:grid.63984.30 schema:alternateName Meakins-Christie Laboratories, and Translational Research in Respiratory Diseases Program, McGill University Health Centre and Research Institute, Montreal, QC, Canada
    375 schema:name Meakins-Christie Laboratories, and Translational Research in Respiratory Diseases Program, McGill University Health Centre and Research Institute, Montreal, QC, Canada
    376 rdf:type schema:Organization
     




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