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):
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Interventions | Flow rates of 15, 30, and 45 litres per minute were tested in a randomized order for each device.
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. |
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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 |
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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. |