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

Rittayamai 2014.

Study characteristics
Methods RCT, cross‐over design. Single‐centre
Participants Total number of randomized participants: 17
Setting: respiratory ICU; Bangkok, Thailand
Inclusion criteria: mechanically ventilated patients who were 18 years of age, successfully weaned by spontaneous breathing, trial with oxygen T‐piece or low level of pressure support for 120 minutes, and ready for endotracheal extubation
Exclusion criteria: haemodynamic instability or decreased level of consciousness; patients who lacked co‐operation, tracheotomized patients, and pregnant women
Baseline characteristics:
  • Age, mean (SD): 66.8 (± 13.8) years

  • Gender, M/F: 10/7

  • BMI, mean (SD): not reported

  • SAPS II, mean (SD): 30.9 (± 4.4)

  • Respiratory rate, mean (SD): recorded before each cross‐over period: baseline 1: 20.3 (± 4.5); baseline 2: 21.7 (± 3.8) breaths/min

  • PaCO2: not reported

  • PaO2/FiO2: not reported

Interventions Intervention group (HFNC):
  • Details: HFNC, Optiflow system, Fisher & Paykel Healthcare; initial inspiratory flow of 35 L/min, and FiO2 adjusted to achieve SpO2 ≥ 94% within the first 5 minutes and to maintain this setting for 30 minutes


Control group (standard oxygen therapy):
  • Details: Non‐rebreather face mask, 6 to 10 L/min to achieve SpO2 94% for another 30 minutes

Outcomes Dyspnoea, patient comfort, breathing frequency, heart rate blood pressure, SpO2
Notes Funding/declarations of interest: study authors did not report funding sources. They disclosed no conflicts of interest.
Study dates: August to December 2011
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Methods used to generate group allocation not stated
Allocation concealment (selection bias) Unclear risk Methods of allocation concealment not stated
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 Unable to blind outcome assessors owing to nature of the intervention: we did not anticipate that this would influence the assessment of objective outcome measures.
Blinding of outcome assessors (subjective measures) Low risk Unable to blind outcome assessors owing to nature of the intervention. Participants were outcome assessors for comfort: We did not expect that this would influence the outcome data.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No statement of how many reported. No participant numbers in tables or graphs
Selective reporting (reporting bias) Unclear risk Trial registration not reported in paper. Unable to establish whether outcomes were reported according to pre‐published protocol or trial registration documents
SpO2 and mean arterial pressure not reported for all time points set out in methods
Other bias Low risk We identified no other risks of bias.