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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT00786292
Eligibility Criteria:
Inclusion Criteria:
* age 18 to 75 yrs
* 150 mmHg \< PaO2/FIO2 \< 300 mmHg
* mechanical ventilation with PSV or BIPAP
* less than 15 days of mechanical ventilation
* at least 20% of minute ventilation originated from spontaneous breathing
Exclusion Criteria:
* BMI \> 35
* esophageal disease
* neuromuscular disease
* instable thorax
* pneumothorax
* head trauma
* brain injury
* increased intracranial pressure
* agitation
* increased need for vasoactive drugs
* chronic lung disease
* acute coronary disease
* participation in another clinical trial within the last 4 weeks at enrollment
Interruption criteria:
* acute change of mental status
* SaO2 \< 92%
* pHa \< 7.30
* respiratory rate \> 30 or \< 6 /min
* dyspnea
* diaphragm/thorax antagonism
* diaphoresis
* abnormal use of respiratory muscles
* increase of the heart rate above 120% of baseline or absolute value \< 60 or \> 130 /min
* mean arterial pressure above 120% of baseline or absolute value \< 70 or \> 110 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00786292
Study Brief:
Protocol Section:
NCT00786292