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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01743105
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has acute respiratory distress defined by a respiratory rate \> 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) \<90% and / or pH \<7.35 and carbon dioxide partial pressure (pCO2) \> 6 kPa (45 mm Hg)
* The patient breathes spontaneously (no respirator)
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient or his/her representative refuses to sign the consent
* It is impossible to correctly inform the patient, or to correctly inform his/her representative
* The patient is pregnant, parturient, or breastfeeding
* The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...).
* Patient admitted with respiratory support treatment in progress
* Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01743105
Study Brief:
Protocol Section:
NCT01743105