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Phrenic Nerve Stimulation-Induced Lung ReAeration Trial (PIRAT)

Primary Purpose

Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lungpacer PROTECT Diaphragm Pacing Therapy
Sponsored by
Lungpacer Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital La Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PROTECT Diaphragm Pacing Therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Successful LIVE catheter placement
LIVE Catheter was successfully inserted into the left subclavian vein, positioned in accordance with the LIVE Catheter IFU, and the diaphragm was stimulated.
Alveolar-arterial (A-a) gradient
Alveolar-arterial (A-a) gradient documenting gas exchange during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Cardiac output index
Pulse contour cardiac output index assessed by transpulmonary thermodilution during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Regional lung ventilation
Regional lung ventilation assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Regional lung atelectasis
Regional lung atelectasis assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Serious adverse events
Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.

Full Information

First Posted
April 8, 2021
Last Updated
October 3, 2023
Sponsor
Lungpacer Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04844892
Brief Title
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
Acronym
PIRAT
Official Title
A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lungpacer Medical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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 patients. By delivering electrical stimulation to the phrenic nerves, which in turn causes the diaphragm muscle to contract, the PROTECT DPTS is intended to protect the diaphragm from atrophy and preserve lung mechanics to reduce lung inflammation and injury associated with short-term mechanical ventilation. Sustained lung and diaphragm health during early mechanical ventilation is expected to reduce the risk of comorbidities, improve clinical outcomes such as weaning success, and thereby reduce the number of patients who require prolonged mechanical ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROTECT Diaphragm Pacing Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lungpacer PROTECT Diaphragm Pacing Therapy
Other Intervention Name(s)
Lungpacer PROTECT DPTS
Intervention Description
PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.
Primary Outcome Measure Information:
Title
Changes in PaO2/FiO2 ratio
Description
The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Successful LIVE catheter placement
Description
LIVE Catheter was successfully inserted into the left subclavian vein, positioned in accordance with the LIVE Catheter IFU, and the diaphragm was stimulated.
Time Frame
Day 1
Title
Alveolar-arterial (A-a) gradient
Description
Alveolar-arterial (A-a) gradient documenting gas exchange during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Time Frame
Day 1
Title
Cardiac output index
Description
Pulse contour cardiac output index assessed by transpulmonary thermodilution during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Time Frame
Day 1
Title
Regional lung ventilation
Description
Regional lung ventilation assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Time Frame
Day 1
Title
Regional lung atelectasis
Description
Regional lung atelectasis assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Time Frame
Day 1
Title
Serious adverse events
Description
Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.
Time Frame
Day 5
Other Pre-specified Outcome Measures:
Title
Days until successful weaning
Time Frame
Day 5
Title
Mortality
Time Frame
Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dres, MD
Organizational Affiliation
AP-HP Hôpital La Pitié-Salpêtrière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

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