Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

Acute Respiratory Distress Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844892
• Other study ID #: P-400
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: February 13, 2023

Study information

• Verified date: October 2023
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 13, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ventilation Therapy; Complications

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital La Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Days until successful weaning		Day 5
Other	Mortality		Day 5
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serious adverse events	Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.	Day 5