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. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2

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
  1. Isolated non‐penetrating TBI or adults with multiple trauma with TBI with GCS 8 or less (inclusive), expected need for intubation and mechanical ventilation > 24 hours

  2. Recruitment within 18 hours after admission to ICU

  3. Time from TBI < 36 hours

  4. Informed consent from next of kin


Exclusion criteria
  1. Age < 18 or > 65 years

  2. Anticipated brain death in 12 hours or otherwise moribund adults expected to die in 24 hours

  3. Expected need for mechanical ventilation < 24 hours

  4. Insufficient oxygenation assessed by a clinician

  5. Adults with multiple trauma with brain injury and severe abdominal, thoracic, or pelvic injury possibly affecting oxygenation

  6. No consent

  7. Insufficient oxygenation with the treatment modality of the lower oxygenation group (PaO2 < 13 kPa or SpO2 < 95% with FiO2 of 0.40 and PEEP of 10)

  8. Oxygenation failure probable during ICU care

  9. Penetrating TBI

  10. Suspected pregnancy (perform urinary or serological pregnancy test if suspected)

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
Outcomes
  1. Laboratory markers during the first 3 days

  2. Pulmonary function (PaO2/FiO2 ratio, ARDS, atelectasis, pneumonia)

  3. Length of mechanical ventilation

  4. Length of ICU stay

  5. Length of hospital stay

  6. Death

  7. Extended Glasgow Outcome Scale

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.
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