FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy ... View Full Text


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Article Info

DATE

2018-06-04

AUTHORS

Padmanabhan Ramnarayan, Paula Lister, Troy Dominguez, Parviz Habibi, Naomi Edmonds, Ruth R. Canter, Jerome Wulff, David A. Harrison, Paul M. Mouncey, Mark J. Peters,

ABSTRACT

BACKGROUND: Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care. METHODS: In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT. RESULTS: Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2). CONCLUSIONS: Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients. TRIAL REGISTRATION: clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015. More... »

PAGES

144

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13054-018-2080-3

DOI

http://dx.doi.org/10.1186/s13054-018-2080-3

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1104385505

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29866165


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28 schema:description BACKGROUND: Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care. METHODS: In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT. RESULTS: Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2). CONCLUSIONS: Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients. TRIAL REGISTRATION: clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015.
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36 CPAP patients
37 Group B 84/118
38 HFNC patients
39 NCT02612415
40 NRS patients
41 RCTs
42 adverse events
43 airway pressure
44 algorithm
45 analysis
46 assistance
47 breathing
48 cannula therapy
49 care
50 care settings
51 changes
52 children
53 choice
54 conduct
55 consent
56 continuous positive airway pressure
57 critical care
58 critical care setting
59 data
60 day 28
61 days
62 design
63 eligible patients
64 emergency situations
65 envelope
66 events
67 feasibility
68 first-line mode
69 first-line support
70 future RCTs
71 future large pragmatic RCT
72 group A
73 group B
74 guardians
75 high-flow nasal cannula therapy
76 ill children
77 intention
78 intubation
79 large national RCT
80 large pragmatic RCT
81 measures
82 minor changes
83 mode
84 more patients
85 multi-centre pilot RCT
86 multicentre pilot
87 nasal cannula therapy
88 national RCT
89 non-invasive respiratory support
90 opaque envelopes
91 order
92 outcome measures
93 outcomes
94 parents/guardians
95 participants
96 patient outcomes
97 patients
98 pediatric critical care
99 pediatric critical care setting
100 period
101 pilot
102 pilot RCT
103 pilot trial
104 popular mode
105 positive airway pressure
106 pragmatic RCT
107 pressure
108 primary outcome measure
109 primary study outcome
110 procedure
111 randomisation
112 range
113 respiratory support
114 safety
115 setting
116 situation
117 study outcomes
118 support
119 therapy
120 treat analysis
121 treatment
122 treatment algorithm
123 trials
124 ventilator-free days
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