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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT06477861
Eligibility Criteria:
Inclusion Criteria:
Age from 18 to 65 years (male or female). Patients fulfilling criteria of ARDS as per Berline definition who will be admitted to ICU , intubated and MV more than 48 hours will be included in this study.
Fulfillment of Criteria of readiness for ARDS as per Berline definition :
1. an acute onset (\<1 week of a known clinical insult or new or worsening respiratory symptoms),
2. respiratory failure not primarily due to hydrostatic edema,
3. bilateral opacities on a chest radiograph (not fully explained by effusions, lobar or lung collapse, or nodules), and
4. \<300 mmHg of the ratio of arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2) with 5 cm H2O of positive end-expiratory pressure (PEEP) or continuous positive airway pressure. To facilitate the estimation of the ARDS prognosis, the Berline definition classifies the severity of ARDS into 3 categories: mild (200 mmHg \< PaO2/FiO2 \< 300 mmHg), moderate (100 mm Hg \< PaO2/FiO2 \<200 mmHg), and severe (PaO2/FiO2 \< 100 mmHg).
Exclusion Criteria:
* Non intubated ICU admissions
* Non-invasive ventilated patients.
* Age less than 18 years or more than 65 years of age
* Open chest wall trauma.
* Patient requiring Extra Corporal Membrane Oxygenator
* Patients with increased intrabdominal pressure interfering with mechanical ventilator parameters measurements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06477861
Study Brief:
Protocol Section:
NCT06477861