Fernandez 2017.
Study characteristics | ||
Methods | RCT, parallel‐group design. Multicentre study | |
Participants |
Total number of randomized participants: 155 Setting: 4 ICUs; Spain Inclusion criteria: adults receiving MV for > 12 hours and ready for scheduled extubation after a SBT; at high risk for extubation failure Exclusion criteria: tracheotomy; inability to follow commands; do‐not‐reintubate order; hypercapnia during SBT Baseline characteristics: Intervention group (HFNC):
Control group (conventional oxygen therapy):
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Interventions | Intervention group:
Control group:
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Outcomes | Respiratory failure within 72 hours post‐extubation (NIV as rescue treatment was discouraged but given at discretion of attending team); reintubation; ICU and hospital lengths of stay; hospital mortality | |
Notes |
Funding/declarations of interest: funding not reported. Two authors received conference fees or postdoctoral grant from Fisher & Paykel Healthcare Ltd. Study dates: 2013 to 2014 Note: study terminated early owing to low recruitment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization was performed via a computerized random‐number table in blocks of four for each hospital”. |
Allocation concealment (selection bias) | Low risk | Quote: "“allocation was concealed through numbered opaque envelopes”. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not possible. Although we expected that this would not influence outcome data, we could not be certain of this. |
Blinding of outcome assessors (objective outcomes) | Low risk | Blinding of outcome assessors is not described; we did not anticipate that this would influence the assessment of objective outcome measures |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | High risk | Study was prospectively registered with a clinical trials register (NCT01820507). We noted that some outcomes were reported in the published report but not listed in the trials register documents (hospital and ICU lengths of stay); this could indicate risk of selective reporting bias for these outcomes. |
Other bias | Low risk | We identified no other sources of bias. |