STimulation to Activate RespIration (NCT06832306) | Clinical Trial Compass
RecruitingNot Applicable
STimulation to Activate RespIration
United States, Canada30 participantsStarted 2025-05-28
Plain-language summary
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18 years or older, and
. Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and
. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and
. Have arterial hypoxemia defined by one of:
. Have been mechanically ventilated for AHRF in the ICU for \<96 hours at the time of enrolment, and
. Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves inserting a device to stimulate breathing muscles in people who are on a ventilator with serious lung failure — how would that insertion procedure work for my specific situation, and what are the risks involved?
2Since this trial is described as Phase NA and appears focused on whether the device can be successfully inserted and used rather than whether it improves survival or recovery, does that mean we don't yet know if this approach actually helps patients with ARDS or acute respiratory failure like mine?
3The trial measures whether stimulation can be started within 18 hours of meeting certain 'readiness' criteria — what would make someone ready or not ready for that step, and how would my current condition affect whether that window is even achievable?
4One of the goals is to deliver rehabilitation sessions at least once a day on most ventilator days — given how serious my condition is right now, is that level of daily activity realistic for me, and how does it compare to the rehabilitation I'd get outside of this trial?
5Before considering this trial, would it make sense to first try standard treatments for moderate or severe ARDS, and what would my care team be watching for to decide if those weren't working?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria
Timeframe: Within 18 hours of meeting readiness to stimulate criteria
2
Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console)
Timeframe: 30 days
3
Rehabilitation sessions delivered at least once per day on >50% of days when the patient was breathing in assisted (patient-triggered) mechanical ventilation
. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.
. Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis).
. Broncho-pleural fistula at the time of eligibility assessment.
. Require extracorporeal membrane oxygenation.
. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
. BMI \>70 kg/m2.
. Contraindications to left internal jugular vein or left subclavian vein catheterization (e.g., infection at the access site, known central venous stenosis, septic thrombophlebitis, left internal jugular ECMO cannula in situ, poor target vessels).
. Patient expected to transition to fully palliative care within 72 hours of enrollment.