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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02871102
Eligibility Criteria:
Inclusion Criteria:
* Admitted to the Intensive Care Unit
* Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
* Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of \<300 or SpO2/FiO2 \<315)
Exclusion Criteria:
* Inability to obtain surrogate consent
* Presence of specified comorbidities:
1. pregnancy
2. pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented \< 1L or baseline hypercapnia
3. cerebral edema
4. known intra-cranial abnormality
5. acute coronary syndrome
* Endotracheal or tracheostomy cuff leak
* Chest tube with persistent air leak
* Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)
* Presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing
* Intrinsic PEEP of \> 5 cmH2O
* Assessment of study staff or patient's attending physician that the patient would not be a good study participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02871102
Study Brief:
Protocol Section:
NCT02871102