- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05465083
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure (STIMULUS)
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure: The STIMULUS I Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The diaphragm is the main muscle of breathing and for most of us therefore is continuously being used (and hence exercised) when in health. When people are unwell with severe breathing difficulties to the degree that their lungs are needing a lot of support from a breathing machine (ventilator) in the intensive care unit (ICU), or are recovering from major lung/chest surgery on a ventilator in ICU, the diaphragm can quickly start to weaken from its inactivity. This means that even when starting to recover from the underlying medical problem, or from the surgery itself, the diaphragm may be unable perform well enough to take over the work of breathing once again. This can lead to not only longer times on the ventilator (time to gradually rebuild diaphragm strength by rehabilitation and physiotherapy) but also therefore longer times in ICU and in hospital with the risk of complications that can be associated with this.
Stimulating the diaphragm by use of a pacemaker (electrical stimulation) is an established treatment for a number of patients with certain types of long-term breathing problems. These pacemakers are permanent and are inserted by invasive surgical methods. More recently however, there have also been a number of studies looking to see if it is possible to safely, temporarily and less invasively stimulate the diaphragm of patients who only have temporary diaphragm inactivity. This has been done either during surgery or during their intensive care stay. A number of methods of temporarily stimulating the diaphragm have been looked at, but the simplest has been to integrate the function of stimulating the nerves (that ultimately control the diaphragm) with a catheter that is frequently placed into a vein in the neck to enable delivery of medications during surgery and in ICU.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenna Wong, MSc
- Phone Number: 7613 4163404800
- Email: jenna.wong@uhn.ca
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Recruiting
- University Health Network
-
Contact:
- Jenna Wong, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Group 1: Acute hypoxemic respiratory failure (AHRF)
Inclusion Criteria:
- 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
Inclusion Criteria:
- Age 18 to 65 years old
- Are listed for pulmonary thromboendarterectomy
- Have pulmonary vascular resistance < 1000 dynes.sec.cm-5
Group 3: Lung transplant
Inclusion Criteria:
- Age 18 years or older
- Are listed for bilateral lung transplant for a primary indication of idiopathic pulmonary fibrosis with no plan for concomitant transplant of other solid organs
All groups
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lungpacer AeroPace Protect System
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. |
AeroPace Catheter will be placed percutaneously into the left internal jugular vein or left subclavian vein and stimulating electrodes mapped for therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of placing AeroPace Catheter
Time Frame: 30 days
|
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:
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30 days
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Safety of AeroPace Catheter
Time Frame: 30 days
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 7 days
|
7 days
|
|
The proportion of time that adequate diaphragm activation is maintained during phrenic nerve stimulation and during the absence of phrenic nerve stimulation.
Time Frame: 7 days
|
This is defined as the percentage of hours the patient has an Edi ≥ minimum Edi required to maintain Pocc ≤ -5 cm H2O.
|
7 days
|
The proportion of hours in which the maintenance of diaphragm activation is due to LAPS-PNS rather than endogenous patient respiratory effort.
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ewan Goligher, MD, PhD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-5516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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