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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04607551
Eligibility Criteria:
Inclusion Criteria:
1. Severe ARDS refractory to conventional therapy placed on VV-ECMO support in the preceding 48h.
2. Obtain informed consent from a close relative or surrogate. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
Close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
3. Social security registration
Exclusion Criteria:
1. Age \<18 and \>75
2. Pregnancy and breastfeeding woman
3. Initiation of VV-ECMO \>48 h
4. Resuscitation \>10 minutes before ECMO
5. Irreversible neurological pathology
6. End-stage chronic lung disease
7. ARDS secondary to an abdominal surgery
8. Contraindications for PP
9. Irreversible ARDS with no hope for lung function recovery
10. Patient moribund on the day of randomization, SAPS II \>90
11. Liver cirrhosis (Child B or C)
12. Chronic renal failure requiring hemodialysis
13. Lung transplantation
14. Burns on more than 20 % of the body surface
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04607551
Study Brief:
Protocol Section:
NCT04607551