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Phrenic Nerve Stimulation for Respiratory Insufficiency (STIMULUS Trial)

N/A

Waitlist Available

Led By Ewan Goligher, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

STIMULUS Trial Summary

This trial is testing a new way to help people who need a lot of help breathing. It involves stimulating a nerve that goes to the diaphragm to try to keep it working for up to a week.

Eligible Conditions

Acute Hypoxemic Respiratory Failure
Diaphragm Injury
Lung Injury

STIMULUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of placing AeroPace Catheter

Safety of AeroPace Catheter

Secondary outcome measures

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

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

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

STIMULUS Trial Design

1Treatment groups

Experimental Treatment

Group I: Lungpacer AeroPace Protect SystemExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lungpacer AeroPace Protect System

2023

N/A

~20

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Find a Location

Who is running the clinical trial?

Lungpacer Medical Inc.Industry Sponsor

6 Previous Clinical Trials

392 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,471 Previous Clinical Trials

484,950 Total Patients Enrolled

1 Trials studying Hypoxemic Respiratory Failure

20 Patients Enrolled for Hypoxemic Respiratory Failure

Ewan Goligher, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto

7 Previous Clinical Trials

6,582 Total Patients Enrolled

1 Trials studying Hypoxemic Respiratory Failure

20 Patients Enrolled for Hypoxemic Respiratory Failure

Media Library

Lungpacer AeroPace Protect System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05465083 — N/A

Hypoxemic Respiratory Failure Research Study Groups: Lungpacer AeroPace Protect System

Hypoxemic Respiratory Failure Clinical Trial 2023: Lungpacer AeroPace Protect System Highlights & Side Effects. Trial Name: NCT05465083 — N/A

Lungpacer AeroPace Protect System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05465083 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots available for participants in this experiment?

"The information on clinicaltrials.gov confirms that this particular trial is no longer enrolling patients; the posting went live on December 15th, 2022 and was last updated November 29th of the same year. Fortunately, over 900 other trials are currently actively seeking participants."

Answered by AI

Could you please elucidate who is eligible for this medical experiment?

"This clinical trial is enlisting 20 patients with respiratory distress that range from 18 to 65 years of age. The accepted participants must meet the following specifications: Between the ages of 18 and 65, Invasive mechanical ventilation for not more than 7 days, PaO2:FiO2 ratio declining below 300 (with FiO2 ≥ 0.5 and PEEP ≥ 10 cm H2O) on two consecutive arterial blood gases taken at least 2 hours apart or require venous-venous extracorporeal membrane oxygenation (ECMO), Controlled mechanical ventilation without patient-triggered ventilator breaths nor plans to transition in"

Answered by AI

Does this research project accept minors as participants?

"According to the qualifications for this experiment, only those aged 18-65 are suitable. There are 162 clinical trials that cater specifically to minors and 759 trials targeting seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ewan Goligher 2023. "Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465083.