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:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT03621293
Eligibility Criteria:
Inclusion Criteria:
* ARDS defined as a PF ratio \<300
* Patients under ventilation for \<12 hours
* Stabilization period of 3 hours with standardization of ventilation parameters
Inclusion criterion specific for neurological evaluation:
\- Patient aged between 20 and 89 years
Exclusion Criteria:
* Chronic respiratory failure or on home ventilation (excluding obstructive sleep apnoea)
* Cardiac arrest
* Moribund patients (death likely within 48 hours as assessed by the ICU physician)
* Gaseous embolism
* CO poisoning
* Pregnant women
* Indication for hyperbaric oxygen treatment
* Persistent pneumothorax
* Gaseous gangrene
* DNR or limited care order
Exclusion criteria specific for neurological evaluation:
* History of neurological disorders: cranial trauma, stroke, cerebral tumor, epilepsy, neuro-degenerative disease.
* Psychiatric disorders: bipolar disorder, psychosis, addiction, schizophrenia.
* Lack of autonomy due to previously documented cognitive and/or psychomotor impairment.
* Hearing and/or sight impairment that prevent the patient from performing the study tests
Patients presenting exclusion criteria for the neurological evaluation can nonetheless be included in the study for the evaluation of respiratory function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03621293
Study Brief:
Protocol Section:
NCT03621293