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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT06054503
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patient aged 18 years or above
2. Patient ventilated with the reference ventilators: Servo U - Maquet Critical Care AB, Röntgenvägen 2, 171 54 Solna, Sweden for intensive care unit or Perseus - Drägerwerk AG \& Co. KGaA, Moislinger Allee 53-55, 23542 Lübeck, Germany for operating room
3. Sedated patient with or without NBA (Neuromuscular Blocking Agent)
4. Patient with a positive end-expiratory pressure (PEEP) ≤ 10 cm H2O
5. Patient stable without recent (less than one hour) or planned intervention (such a bronchoscopy, prone positioning, physiotherapy)
6. The primary attending physician approves use of the protocol on the patient
7. Anticipated length of intubation \> 2 hours per patient
8. The patient or legally authorized representative has signed and dated a written Informed Consent Form (ICF) prior to the initiation of any clinical investigation procedures
9. Patient affiliated to the French social security regimen
10. Procedure will be performed at least 30 minutes after inhaled treatment (eg salbutamol)
Exclusion Criteria:
1. Patient with a serious disease, for which the ventilation unplugging during a few seconds could have a serious impact (particularly patients with PaO2/Fi02 \< 150 with pH \< 7,30, with PEEP \> 10 cm H20, or with Fi02 \> 50%)
2. Patient with disease judged by the investigator to be incompatible with the conduct of the clinical investigation procedures or the interpretation of the clinical investigation results (example: IG-bronchopleural fistula)
3. Patient with a significant lower airway obstruction (asthma…), confirmed by ventilator spirometry.
4. Inability to maintain the airway intubation
5. Patient with a recent history of cardiac and/or respiratory arrest
6. Patient with multiple-organ system failure
7. Patient with hemodynamic instability (tachycardia, rapid change of vasopressor)
8. Pregnancy
9. Participation in another clinical investigation at the same time as the present clinical investigation
10. Nitric oxide use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06054503
Study Brief:
Protocol Section:
NCT06054503