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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT02816359
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Acute respiratory failure defined by PaO2/FIO2\< 300 mmHg or pH\<7,35 and pCO2\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:
* New or worsening respiratory symptoms in the previous week.
* Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules
* Respiratory failure not fully explained by cardiac failure or fluid overload
* PaO2/FIO2\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight
* Patient intubated or tracheotomized and receiving mechanical ventilation
* Indication of esophageal measurement decided by the clinician
Exclusion Criteria:
* Contraindication to naso-gastric tube insertion :
* Recent gastro-duodenal ulcer
* Stage III esophageal varices
* Refractory intracranial hypertension
* Unstabilized spine fracture
* Surgical contraindication
* Burns on more than 20 % of the body surface
* Underlying disease with a life expectancy of less than one year
* End-of-life decision before inclusion
* Pregnant or breast-feeding patients
* Subject deprived of freedom, minor, subject under a legal protective measure
* Research team unavailability
* Lack of medical care plan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02816359
Study Brief:
Protocol Section:
NCT02816359