STimulation to Activate RespIration (NCT06832306) | Clinical Trial Compass
RecruitingNot Applicable
STimulation to Activate RespIration
United States30 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 range18 Years
SexALL
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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
✕. 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.
✕
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
✕. 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.