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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT04844892
Eligibility Criteria:
Inclusion Criteria:
* Are 18 years or older
* Have been mechanically ventilated due to moderate ARDS for 48-120h
* Have a PaO2/FiO2 ratio \< 200 and \> 100 at the time of screening with PEEP ≥ 5 cmH2O
* Are expected to remain on mechanical ventilation ≥ 48 hours
* Are under continuous sedation with Richmond Agitation Sedation Scale (RASS) ≤ -3
Exclusion Criteria:
* Septic shock with hemodynamic instability (norepinephrine or epinephrine \< 0.5 gamma/kg/min)
* Catheter access to left subclavian vein deemed impossible
* Use of neuromuscular blocking agents within last 12 hours
* Bacteremia within the last 48 hours or uncontrolled source of infection
* Currently on ECMO
* Enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study
* Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles
* BMI \>45 kg/m2
* Known or suspected phrenic nerve paralysis
* Any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer PROTECT DPTS, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators
* No affiliation to the French health insurance system
* Under curatorship
* Imprisoned
* Known or suspected to be pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04844892
Study Brief:
Protocol Section:
NCT04844892