Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •1. Age less than 18 years
• •2. Greater than 168 hours since ARDS onset
• •3. Pregnant or breastfeeding
• •4. Prisoner
• •5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
• •6. No consent/inability to obtain consent or appropriate legal representative not available
• •7. Physician refusal to allow enrollment in the trial
• •8. Moribund patient not expected to survive 24 hours
• •9. No arterial or central line/no intent to place an arterial or central line
• •10. No intent/unwillingness to follow lung protective ventilation strategy
• •11. Severe hypoxemia defined as SpO2 \< 95 or PaO2 \< 90 on FiO2 ≥ 0.9
• •12. Hemoglobin \< 7.0 g/dL
• •13. Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
• •14. Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
• •15. Coronary artery bypass graft (CABG) surgery within 30 days
• •16. Angina pectoris or use of nitrates with activities of daily living
• •17. Cardiopulmonary disease classified as NYHA class IV
• •18. Stroke (ischemic or hemorrhagic) within the prior 1 month, cardiac arrest requiring CPR within the prior 72 hours, or inability to assess mental status following cardiac arrest
• •19. Burns \> 40% total body surface area (TBSA)
• •20. Severe airway inhalational injury
• •21. Use of high frequency oscillatory ventilation
• •22. Use of extracorporeal membrane oxygenation (ECMO)
• •23. Concomitant use of inhaled pulmonary vasodilator therapy (eg. nitric oxide \[NO\] or prostaglandins)
• •24. Diffuse alveolar hemorrhage from vasculitis
• •25. Concurrent participation in other investigational drug study