Status:
COMPLETED
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
Lead Sponsor:
Lungpacer Medical Inc.
Conditions:
Acute Respiratory Distress Syndrome
Ventilation Therapy; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 im...
Detailed Description
The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04844892
Start Date
August 25 2021
End Date
February 13 2023
Last Update
October 5 2023
Active Locations (1)
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1
Hôpital La Pitié-Salpêtrière
Paris, France, 75651