| Methods |
Prospective, multi‐centre, parallel‐group RCT |
| Participants |
n = 200. Inclusion criteria: ARDS, PaO2/FiO2< 200 at FiO2 ≥ 0.5 and PEEP ≥ 10 in North America, Brazil, Spain and Chile, from 2007 to 2013
Inclusion criteria
Intubated and mechanically ventilated Diagnosis of ARDS based on American‐European consensus criteria Enrolment in study < 48 hours since diagnosis of ARDS For 12‐36 hours (ideally 12‐24 hours) after diagnosis of ARDS, participant must be ventilated as follows: ACVC, tidal volume of 4‐8 mL/kg PBW, plateau pressure ≤ 30 cm H2O, PEEP/FiO2 adjustments based on ARDSnet table, ventilator rate to keep PaCO2 = 35‐60 mmHg During the 12‐36 hour (ideally 12‐24 hour) period, PaO2/FiO2 must remain < 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: ACVC, tidal volume = 6 mL/kg PBW, plateau pressure ≤ 30 cm H2O, inspiratory time ≤ 1 second, PEEP ≥ 10 cm H2O, FiO2 ≥ 0.5, ventilator rate to keep PaCO2 = 35‐60 mmHg No lung recruitment manoeuvres or adjunct therapy Total time on mechanical ventilation < 96 hours at time of randomization
Exclusion criteria
Age < 18 years or > 80 years Weight < 35 kg PBW Body mass index > 60 Intubated 2° to acute exacerbation of a chronic pulmonary disease Acute brain injury (ICP > 18 mmHg) Immunosuppression 2° to chemotherapy or radiation therapy Severe cardiac disease (1 of the following): New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias Positive laboratory pregnancy test Sickle cell disease Neuromuscular disease High risk of mortality within 3 months from cause other than ARDS (e.g. cancer) More than 2 organ failures (not including pulmonary system) Documented lung barotrauma (i.e. chest tube placement other than for fluid drainage) Persistent haemodynamic instability or intractable shock Penetrating chest trauma Enrolment in another interventional study
|
| Interventions |
Treatment: staircase recruitment manoeuvre in PCV to peak of ≤ 60 cm H2O airway pressure for 2 minutes and decremental PEEP titration to determine optimal PEEP. Ongoing ventilation with peak pressure ≤ 30 mmHg to VT 3‐5 mL/kg of PBW, RR ≤ 35/min to PaCO2 40‐50
Control: ARDSnet protocol, VCV, VT < 6 mL/kg of PBW, RR ≤ 35/min to maintain pH of 7.30‐7.45, plateau pressure ≤ 30 mmHg, I:E ratio 1:1‐1:3 |
| Outcomes |
ICU and hospital, 28‐day and 60‐day mortality, ICU length of stay, ventilator‐free days, adverse events (hypotension, hypoxaemia, pneumothorax, arrhythmias, cardiac arrest) |
| Notes |
Contacted the first study author. Trial ceased early owing to low rate of enrolment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Contacted co‐investigators to clarify the procedure. Awaiting full publication |
| Allocation concealment (selection bias) |
Low risk |
Contacted co‐investigators to clarify the procedure. Awaiting full publication |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Open‐label design |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Primary outcome was reported for all enrolled participants. |
| Selective reporting (reporting bias) |
Unclear risk |
Not yet fully reported. Awaiting full publication |
| Intention to treat |
Low risk |
Yes |
