Clinical Trials

Inclusion Criteria:

• All patients between the ages of 18 and 65 years old.
• Endotracheal tube or tracheostomy in place and mechanically ventilated for ≤ 7 days.
• Admitted to a participating ICU.
• Radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural  effusions, atelectasis, or hydrostatic pulmonary edema  
• P/F ratio < 200 with PEEP ≥ 8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values as long as following conditions are met:  
  • SpO2 values are 80-96%;
  • SpO2 is measured ≥10 min after any change in FIO2;  
  • PEEP is ≥ 8 cm H2O;
  • The pulse oximeter waveform tracing is adequate;
  • The qualifying inferred P/F ratio is confirmed 1-6h after initial determination.
• Access to an LAR to provide consent.  
• Criteria 3 AND 4 must be met within 48h of enrollment and randomization, not be fully  explained by hydrostatic pulmonary edema, and must have occurred within 7 days onset  of a condition associated with ARDS.
• Patients may be enrolled and decision about randomization delayed if all criteria other than P/F ratio < 200 are met and then randomized if and when the P/F ratio < 200 (as long as this occurs within 48h of randomization).

Exclusion Criteria:

• ​Missed ARDS window (> 48hrs).  
• Missed NMB window: (> 12 hrs).
• Missed mechanical ventilation window (> 7 days).
• Refractory hypotension (> 0.2 mcg/kg/min of norepinephrine or equivalent dose for 6 h or longer).
• Core temperature < 35.5°C while not receiving CRRT.
• Patient is unable to give consent and no Legally authorized representative is available.
• Significant, active bleeding (>3u blood products and/or surgical/IR intervention).  
• Platelets <10K/mm^3 (uncorrected).
• Active hematologic malignancy.  
• Skin process that precludes cooling device.  
• Moribund, not likelyto survive 72 hours.  
• Pre-morbid condition makes it unlikely that patient will survive 28 days.  
• Do Not Resuscitate status. 
• Not likely to remain intubated for ≥ 48h.  
• Physician of record unwilling to participate.  
• Severe underlying lung disease:  
  • On home O2;
  • On BIPAP (except for OSA);  
  • Prior lung transplantation.
• Pregnant.
• BMI > 50 kg/m2.  
• Known NYHA class IV heart disease.  
• Acute Coronary Syndrome past 30 days (MI, unstable angina).  
• Cardiac arrest within 30 days of enrollment.  
• Burns over > 20% of the body surface.  
• Severe chronic liver disease (Child-Pugh score 12-15).  
• Previously randomized in CHILL study.