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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT04708457
Eligibility Criteria:
Inclusion Criteria:
1. Laboratory confirmed severe acute respiratory infection (SARI) pneumonitis such as Coronavirus disease of 2019 (COVID-19) or influenza, AND
2. ≥5 days of mechanical ventilation, AND
3. Moderate to severe respiratory failure as shown by either the ratio of partial pressure of oxygen and the fracture of inspired oxygen (PaO2:FiO2 Rati)o \<150 for \>6 hours OR the potential of hydrogen (pH) \<7.30 with carbon dioxide (CO2) \>50mmHg for 6 hours, AND
4. Are unable to pass a spontaneous breathing trial.
Exclusion Criteria:
1. Age ≥70 year old
2. Extubation likely in next 24-48 hours
3. Duration of mechanical ventilation ≥7days
4. ≥2 non-pulmonary organ failures (as scored by the sequential oxygen failure assessment (SOFA) score)
5. Need for immediate VV ECMO (as per EOLIA (research study) criteria\*)
6. Requirement for VA ECMO
7. Clinical frailty or ≥2 major comorbidities
8. The physician deems the study is not in the patient's interest
* EOLIA criteria (P:F \<50 for 3 hours, P:F\<80 for 6 hours, pH\<7.25 with carbon dioxide partial pressure (PCO2) \>60 for \>6 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04708457
Study Brief:
Protocol Section:
NCT04708457