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Phrenic Nerve Stimulation-Induced Lung ReAeration Trial (PIRAT)

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ClinicalTrials.gov Identifier: NCT04844892
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Lungpacer Medical Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Ventilation Therapy; Complications Device: Lungpacer PROTECT Diaphragm Pacing Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Lungpacer PROTECT DPTS


Outcome Measures
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Primary Outcome Measures :
  1. Changes in PaO2/FiO2 ratio [ Time Frame: Day 1 ]
    The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.


Secondary Outcome Measures :
  1. Successful LIVE catheter placement [ Time Frame: Day 1 ]
    LIVE Catheter was successfully inserted into the left subclavian vein, positioned in accordance with the LIVE Catheter IFU, and the diaphragm was stimulated.

  2. Alveolar-arterial (A-a) gradient [ Time Frame: Day 1 ]
    Alveolar-arterial (A-a) gradient documenting gas exchange during each acute standard of care ventilation and acute PROTECT pacing therapy session.

  3. Cardiac output index [ Time Frame: Day 1 ]
    Pulse contour cardiac output index assessed by transpulmonary thermodilution during each acute standard of care ventilation and acute PROTECT pacing therapy session.

  4. Regional lung ventilation [ Time Frame: Day 1 ]
    Regional lung ventilation assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.

  5. Regional lung atelectasis [ Time Frame: Day 1 ]
    Regional lung atelectasis assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.

  6. Serious adverse events [ Time Frame: Day 5 ]
    Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.


Other Outcome Measures:
  1. Days until successful weaning [ Time Frame: Day 5 ]
  2. Mortality [ Time Frame: Day 5 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844892


Contacts
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Contact: Nawzer Mehta, PhD 4844809667 nmehta@lungpacer.com
Contact: Benoit Hallier bhallier@lungpacer.com

Locations
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France
Hôpital La Pitié-Salpêtrière Recruiting
Paris, France, 75651
Contact: Nabila Fares    +33 1 42 16 78 13    nabila.fares@aphp.fr   
Principal Investigator: Martin Dres, MD         
Sponsors and Collaborators
Lungpacer Medical Inc.
Investigators
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Principal Investigator: Martin Dres, MD AP-HP Hôpital La Pitié-Salpêtrière
More Information
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Responsible Party: Lungpacer Medical Inc.
ClinicalTrials.gov Identifier: NCT04844892    
Other Study ID Numbers: P-400
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury