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. 2021 Mar 4;2021(3):CD010172. doi: 10.1002/14651858.CD010172.pub3

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):
  • Age, mean (SD): 67.3 (± 12.1) years

  • Gender, M/F: 46/32

  • BMI, > 30 kg/m2, n: 14

  • APACHE II, mean (SD) : 21 (± 8.8)

  • PaCO2, mean (SD): not reported

  • PaO2/FiO2, mean (SD): not reported


Control group (conventional oxygen therapy):
  • Age, mean (SD): 69.7 (± 13.0) years

  • Gender, M/F: 55/22

  • BMI, > 30 kg/m2, n: 18

  • APACHE II, mean (SD): 21 (± 8.2)

  • PaCO2, mean (SD): not reported

  • PaO2/FiO2, mean (SD): not reported

Interventions Intervention group:
  • Randomized, n = 78; losses, n = 0; analysed, n = 78

  • Details: HFNC via Optiflow, flow initiated at 40 L/min, humidifier temperature at 37 ºC, but switched to noninvasive mode (34 ºC) if participant felt excessive warmth. Oxygen titrated to achieve SpO2 at 92 to 95%. After 24 hours, received conventional therapy


Control group:
  • Randomized, n = 77; losses, n = 0; analysed, n = 77

  • Details: oxygen after extubation via nasal prongs or facemask, regulated by Venturi. Oxygen titrated to achieve SpO2 at 92 to 95%. After 24 hours, continued to receive conventional therapy

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
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.