Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

NCT04844892 | Completed

• 1 other identifier: P-400
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Acute Respiratory Distress Syndrome; Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• Changes in PaO2/FiO2 ratio

  The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.

  Day 1

Secondary Outcomes (6)

• Successful LIVE catheter placement

  Day 1

• Alveolar-arterial (A-a) gradient

  Day 1

• Cardiac output index

  Day 1

• Regional lung ventilation

  Day 1

• Regional lung atelectasis

  Day 1

Other Outcomes (2)

• Days until successful weaning

  Day 5

• Mortality

  Day 5

Study Arms (1)

PROTECT Diaphragm Pacing Therapy

EXPERIMENTAL

Device: Lungpacer PROTECT Diaphragm Pacing Therapy

Interventions

Lungpacer PROTECT Diaphragm Pacing Therapy DEVICE

PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.

Also known as: Lungpacer PROTECT DPTS

PROTECT Diaphragm Pacing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lungpacer Medical Inc.: lead

Study Sites (1)

Hôpital La Pitié-Salpêtrière

Paris, 75651, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Martin Dres, MD

  AP-HP Hôpital La Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: August 25, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 13, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)