Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure

NCT05465083 | Completed DMC

• 2 other identifiers: 22-581521-5516
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center proof-of-concept clinical trial designed to establish the feasibility of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the first 24 hours and for up to seven days of mechanical ventilation in patients who are likely to require more than 48 hours of invasive mechanical ventilation.

Conditions

Acute Hypoxemic Respiratory Failure; Diaphragm Injury; Lung Injury

Outcome Measures

Primary Outcomes (2)

• Feasibility of placing AeroPace Catheter

  Feasibility will be defined as the device being successfully deployed in at least 11 of the 20 patients. Successful deployment of the device defined as: * AeroPace Catheter insertion and placement successfully confirmed * Initial Catheter electrode mapping/calibration successfully completed * Adequate diaphragm activation achieved, defined as hourly Edi level sufficient to generate a Pocc of ≤ -5 cm H2O, for at least 50% of LAPS-PNS stimulated breaths over the first 24 hours after commencing stimulation.

  30 days

• Safety of AeroPace Catheter

  The technique will be considered safe if there are no unexpected serious adverse events (USADEs) and the incidence of device- or procedure-related SAEs is below that established in literature.

  30 days

Secondary Outcomes (3)

• LAPS-PNS successfully achieved at the time of the mapping/calibration procedure on each of the subsequent days up to the end of the study intervention period

  7 days

• The proportion of time that adequate diaphragm activation is maintained during phrenic nerve stimulation and during the absence of phrenic nerve stimulation.

  7 days

• The proportion of hours in which the maintenance of diaphragm activation is due to LAPS-PNS rather than endogenous patient respiratory effort.

  7 days

Study Arms (1)

Lungpacer AeroPace Protect System

EXPERIMENTAL

The PNS device used for this study will be the most recent AeroPace central venous catheter from Lungpacer Medical Inc (Vancouver, BC). It is an 8.5F 23cm triple lumen central venous catheter with 30 electrodes arranged in two arrays (distal 9 electrodes intended to capture the right phrenic nerve and the 21 proximal to capture the left phrenic nerve). It is inserted via the left internal jugular or left subclavian vein where it is placed in the proximal superior vena cava (SVC) at or above the cavo-atrial junction. The AeroPace system monitors airway pressure to detect ventilator-triggered controlled mechanical breaths and patient-triggered assisted mechanical breaths. In response to detection of native respiratory efforts the PNS lies quiescent.

Device: Lungpacer AeroPace Protect System

Interventions

Lungpacer AeroPace Protect System DEVICE

AeroPace Catheter will be placed percutaneously into the left internal jugular vein or left subclavian vein and stimulating electrodes mapped for therapy.

Lungpacer AeroPace Protect System

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, and,
• Invasive mechanical ventilation for ≤ 7 days, and,
• Have hypoxemia as defined by one of:
• A PaO2:FiO2 ratio \< 300 and PEEP ≥ 5 cm H2O, or
• SpO2:FiO2 \< 315% on PEEP ≥ 5 cm H2O in absence of an available arterial blood gas, and in the presence of a reliable Sp)2 trace and a SpO2 \< 97%, or
• Are receiving inhaled nitric oxide for acute hypoxemia, or
• Require extracorporeal membrane oxygenation, and,
• Are on controlled mechanical ventilation with no patient-triggered ventilator-delivered breaths with no imminent plan to transition to assisted ventilation within 6 hours, and,
• Are not expected to be liberated from mechanical ventilation within the next 48 hours (from time of enrollment)
• Group 2: Pulmonary endarterectomy
• Age 18 to 65 years old
• Are listed for pulmonary thromboendarterectomy
• Have pulmonary vascular resistance \< 1000 dynes.sec.cm-5
• Group 3: Lung transplant
• Age 18 years or older

You may not qualify if:

• Pregnant or lactating
• Previously diagnosed neuromuscular disorder or known phrenic nerve injury
• BMI \>70kg/m2
• Implanted electronic cardiac or neurostimulation device in situ
• Contraindications to left internal jugular or subclavian vein catheterization (e.g., infection over the site, known central venous stenosis, septic thrombophlebitis, left internal jugular ECMO cannula in situ) and/or subclavian vein catheterization (to include poor target vessel)
• Contraindications to esophageal balloon or EMG catheter placement (e.g. active bleeding or high-grade esophageal varices with recent bleeding or banding in previous 14 days, recent esophageal surgery or esophageal rupture)
• Patient transitioning fully to palliative care
• Treating clinician deem enrollment not clinically appropriate for other reason
• Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Lungpacer Medical Inc.: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• Morris IS, Bassi T, Bellissimo CA, Bootjeamjai P, Roman-Sarita G, de Perrot M, Donahoe L, McRae K, Dianti J, Del Sorbo L, Keshavjee S, Cypel M, Reynolds SC, Dres M, Thakkar V, Mehta N, Brochard L, Ferguson ND, Goligher EC. Continuous On-Demand Diaphragm Neurostimulation to Prevent Diaphragm Inactivity During Mechanical Ventilation: A Phase 1 Clinical Trial (STIMULUS). Am J Respir Crit Care Med. 2025 Aug;211(8):1442-1451. doi: 10.1164/rccm.202407-1483OC.

  PMID: 40043207 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: February 4, 2023
• Primary Completion: October 15, 2023
• Study Completion: November 10, 2023
• Last Updated: December 11, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)