The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.