Phrenic Nerve Stimulation-Induced Lung ReAeration Trial (PIRAT)

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Ventilation Therapy; Complications
• Intervention / Treatment: Device: Lungpacer PROTECT Diaphragm Pacing Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75651
    • Hôpital La Pitié-Salpétrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROTECT Diaphragm Pacing Therapy	Device: Lungpacer PROTECT Diaphragm Pacing Therapy; PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.; Other Names: Lungpacer PROTECT DPTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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.	Day 1
Regional lung ventilation	Regional lung ventilation assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.	Day 1
Regional lung atelectasis	Regional lung atelectasis assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.	Day 1
Serious adverse events	Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.	Day 5

Other Outcome Measures

Outcome Measure	Time Frame
Days until successful weaning	Day 5
Mortality	Day 5

Collaborators and Investigators

• Sponsor: Lungpacer Medical Inc.
• Investigators: Principal Investigator: Martin Dres, MD, AP-HP Höpital la Pitié-Salpétrière

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: P-400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No