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:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT00431158
Eligibility Criteria:
Inclusion Criteria:
* Intubated and mechanically ventilated
* Diagnosis of ARDS using American-European consensus criteria
* Enrollment in study \< 48 hours since diagnosis of ARDS
* For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
* During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain \< 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
* No lung recruitment maneuvers or adjunct therapy.
* Total time on mechanical ventilation \< 96 hrs. 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 chemo- or radiation therapy
* Severe cardiac disease(one of the following): New York Heart Association Class 3 or 4, 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 hemodynamic instability or intractable shock
* Penetrating chest trauma
* Enrollment in another interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00431158
Study Brief:
Protocol Section:
NCT00431158