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. 2017 May 30;2017(5):CD010172. doi: 10.1002/14651858.CD010172.pub2

Chanques 2013.

Study characteristics
Methods RCT, cross‐over study. Single‐centre study
Participants Total number of participants: 10
Setting: medical‐surgical ICU; Montpelier, France
Inclusion criteria: ≥ 18 years old hospitalized in a medical‐surgical ICU, planned for tracheostomy tube removal which was placed in the ICU for weaning from mechanical ventilation
Exclusion criteria: pregnancy, adult under tutelage, contraindications for NIV
Baseline characteristics (all patients):
  • Age: 54 to 66 years

  • Respiratory rate, median (IQR): 18 (22 to 20) breaths/min

  • PaCO2: not reported

  • PaO2/FiO2: not reported

Interventions Flow rates of 15, 30, and 45 litres per minute were tested in a randomized order for each device.
  • High‐flow face mask with a reservoir bag

  • Optiflow high‐flow nasal cannulae

  • Boussignac oxygen therapy system&


For each device and flow rate, participants were asked to have their mouth open and mouth closed in a randomized order. Each device was used for 5 minutes, with 15‐minute washout between treatments.
Outcomes Tracheal pressure, FiO2 delivered, respiratory discomfort, respiratory rate (at end of each treatment period), noise intensity
Notes Funding sources/declarations of interest: Study authors disclosed funding of €3000 from Fisher & Paykel Healthcare Ltd, France, which was used to acquire technical equipment and clinical research insurance, and to present results at scientific meetings.
Study dates: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomization not stated
Allocation concealment (selection bias) Unclear risk Method 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 Investigators were outcome assessors for objective outcomes, but standardized tools were used for measurement, reducing risk of bias.
Blinding of outcome assessors (subjective measures) Low risk Participants were outcome assessors for respiratory and auditory discomfort on a standardized scale. We did not think this would influence the subjective outcome data.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk One participant was excluded owing to major intolerance to the device but possibly should have been regarded as a treatment failure. In such a small study, this is likely to have had an effect.
Owing to inability of 4 participants in the Boussignac group to adhere to the protocol, it is likely that data were incomplete; however it was not mentioned how this was handled in the analysis.
Selective reporting (reporting bias) Unclear risk ISRCTN15995925. Retrospectively registered in August 2012. Not possible to establish any reporting bias through comparison with the trial register protocol
Other bias Low risk We identified no other risks of bias.