CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Lungpacer AeroPace Protect Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05465083
NCT05465083N/ACompleted
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Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure: the STIMULUS I Clinical Trial

University Health Network, Toronto·interventional·Posted Jul 19, 2022·Updated Dec 11, 2024

In Brief

A clinical study evaluating Lungpacer AeroPace Protect System for Acute Hypoxemic Respiratory Failure and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Hypoxemic Respiratory Failure, Diaphragm Injury, Lung Injury
CountriesCanada
CollaboratorsLungpacer Medical Inc.

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 19, 2022
Enrollment StartFeb 4, 2023
Primary CompletionOct 15, 2023
Study CompletionNov 10, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.0 years ago

Interventions

Lungpacer AeroPace Protect Systemdevice

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