Lång 2018.
| Methods | RCT | |
| Participants |
Sample size: 65 (experimental 38, control 27) Sex (male): experimental 82%, control 85% Age: experimental 45, control 43 Country: Finland Setting: mechanically ventilated adults with traumatic brain disease admitted to the ICU Disease severity score: APACHE II score median 22 Inclusion criteria
Exclusion criteria
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| Interventions |
Experimental: FiO2 of 0.70. Categorized by us as using a high target in the experimental group Control: FiO2 of 0.40. Categorized by us as using a low target in the control group Co‐intervention: not specified Duration: maximum 14 days |
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| Outcomes |
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| Notes | Email sent 6 December 2018 to Dr Lång and a reply was received. It was unclear how the trial was funded. According to protocol, the trial was supported by Kuopio University Hospital. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated that the trial was randomized, but the method of sequence generation was not described |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Only the neurologist assessing the neurological outcomes was blinded. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 8% were lost to follow‐up, and allocation groups were not specified in the publication. The number of participants lost to follow‐up in each group was clarified by email. |
| Selective reporting (reporting bias) | Low risk | The trial was registered prior to randomization (NCT01201291), however quality of life is not reported; however trial authors are planning to publish these results. |
| Other bias | High risk | Unplanned trial stop |