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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07359261
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Body mass index ≥30 kg/m²
* Intubated and receiving passive mechanical ventilation
* Within 24 hours of intubation
* Anticipated need for mechanical ventilation for at least 48 hours
Exclusion Criteria:
* Known or suspected esophageal varices
* Esophageal surgery within 3 months
* Known esophageal stricture or perforation
* Active upper gastrointestinal bleeding
* Severe coagulopathy (INR \>3.0 or platelet count \<30,000/μL)
* Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\<20 mmHg)
* Severe hemodynamic instability at treating physician discretion
* Known pregnancy
* Moribund state with expected survival \<48 hours
* Receiving extracorporeal membrane oxygenation (ECMO)
* Open abdomen post-operatively
* Previous enrollment in this study
* Any other contraindication to esophageal balloon placement as determined by clinical team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07359261
Study Brief:
Protocol Section:
NCT07359261