Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT00750204
Eligibility Criteria:
Inclusion Criteria:
Acute onset of:
1. Arterial Pressure of Oxygen (PaO2) / FiO2 ≤ 300
2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric
3. Requirement for positive pressure ventilation via endotracheal tube, and
4. No clinical evidence of left atrial hypertension.
5. Receiving conventional MV, or lung-protective ventilation (LPV), in the assist control (AC) mode with positive end-expiratory pressure (PEEP) \> 5 cm H2O Criteria 1-3 must occur within a 24-hour period. "Acute onset" is defined as follows: the duration of the hypoxemia criterion (#1) and the chest radiograph criterion (#2) must be \< 7 days at the time of randomization.
Exclusion Criteria:
1. FiO2 \> 70% or PaO2/FiO2 \< 125 or arterial pH \< 7.25
2. Greater than 6 days since all inclusion criteria are met
3. Anticipated to begin weaning from MV within 48 hours
4. Neuromuscular disease that prevents the ability to generate spontaneous tidal volumes.
5. Glasgow Coma Scale (GCS) \< 15 within 1 week of intubation
6. Acute stroke (vascular occlusion or hemorrhage)
7. Current alcoholism or previous daily use of opioids or benzodiazepines before hospitalization
8. Acute meningitis or encephalitis
9. Pregnancy (negative pregnancy test required for women of child-bearing potential) or breast-feeding.
10. Severe chronic respiratory disease
11. Previous barotraumas during the current hospitalization
12. Clinical evidence of bronchoconstriction on bedside examination (i.e., wheezing).
13. Patient, surrogate, or physician not committed to full support
14. Severe chronic liver disease (Child-Pugh Score B or C)
15. International Normalized Ratio (INR) \> 2.0
16. Platelet level \< 50,000
17. Mean arterial pressure \< 65, or patient receiving intravenous vasopressors (any dose of epinephrine, norepinephrine, phenylephrine, or dopamine \> 5 mcg/kg/min)
18. Age \< 16 years old
19. Morbid obesity (greater than 1kg/cm body weight).
20. No consent/inability to obtain consent
21. Unwillingness of the clinical team to use conventional low tidal-volume protocol for MV.
22. Moribund patient not expected to survive 24 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00750204
Study Brief:
Protocol Section:
NCT00750204