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. 2016 Nov 17;2016(11):CD006667. doi: 10.1002/14651858.CD006667.pub3

Xi 2010.

Methods Prospective, multi‐centre RCT
Participants n = 110
Inclusion criteria
  • ARDS (PaO2 ≤ 200 mmHg at FiO2 1.0 and PEEP ≥ 10 cm H2O)

  • Absence of left atrial hypertension or PCWP ≤ 18 mmHg

  • Age > 18 years, stable haemodynamics


Exclusion criteria
  • Acute myocardial infarction within preceding week

  • Preexisting chronic respiratory insufficiency

  • Anatomical chest well abnormalities

  • Chest tube with persistent air leak, pneumothorax or bronchopleural fistula

  • Gross barotrauma in any form

  • Pregnancy

  • Malignant disease or end‐stage chronic disease

  • Anatomical lobectomy within 2 weeks

  • Bone marrow transplantation or lung transplantation

  • Chronic liver disease

  • Intracranial pressure or neuromuscular disease that could impair spontaneous breathing

  • Previous inclusion in this study or participation in another study

Interventions Treatment: RM (CPAP 40 cm H2O for 40 seconds) performed 8‐hourly for first 5 days, unless weaning standard was reached
Both groups: VT 6‐8 mL/kg; Pplat < 30 cmH2O; VCV or PCV for first 24 hours, with any mode thereafter; PEEP titrated to target PaO2 or FiO2 or both; permissive hypercapnia
Outcomes Primary: ICU mortality
Secondary: number of ventilator‐free days; non‐pulmonary organ dysfunction‐free days from day 1 to day 28; 28‐day mortality; percentage of unassisted breathing hours for at least 48 consecutive hours; incidence of barotrauma or pneumatocoele > 2 cm
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Sealed envelopes
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 15 participants were excluded for failure to follow the study protocol.
Selective reporting (reporting bias) Unclear risk 15 participants were excluded for failure to follow the study protocol ‐ 3 in the control group and 12 in the intervention group (not analysed as intention‐to‐ treat).
Intention to treat High risk 15 participants were excluded from final analysis for failure to adhere to study protocol.