Actively Recruiting
STimulation to Activate RespIration
Led by Lungpacer Medical Inc. · Updated on 2026-01-09
30
Participants Needed
6
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
STimulation to Activate RespIration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years or older
- Able to provide informed consent or have a legally authorized representative or substitute decision maker who can provide consent
- Acute onset of new respiratory symptoms or dysfunction within 2 weeks before needing respiratory support
- Arterial hypoxemia defined by one of: PaO2:FiO2 ratio 64300 mm Hg on PEEP 655 cm H2O; or SpO2 6497% on FiO2 650.5 and PEEP 655 cm H2O with reliable SpO2 trace for 2 hours before eligibility assessment; or receiving pulmonary vasodilators for acute hypoxemia; or being ventilated in prone position for acute hypoxemia
- Mechanically ventilated for acute hypoxemic respiratory failure in ICU for less than 96 hours at enrollment
- Expected to require invasive mechanical ventilation for at least 48 hours after enrollment in the opinion of the treating clinician
You will not qualify if you...
- Hypoxemia mainly caused by acute worsening of COPD, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism
- Chronic lung disease (e.g., COPD, pulmonary fibrosis) likely to affect recovery or extubation
- Broncho-pleural fistula at eligibility assessment
- Need for extracorporeal membrane oxygenation
- Pre-existing neurological, neuromuscular, or muscular disorders or known phrenic nerve injury affecting respiratory muscles
- Body mass index over 70 kg/m2
- Contraindications to catheterization of left internal jugular or left subclavian vein (e.g., infection at access site, central venous stenosis, septic thrombophlebitis, ECMO cannula in place, poor target vessels)
- Expected to transition to fully palliative care within 72 hours of enrollment
- Chronic severe liver disease (Child-Pugh Score 6510)
- Treating clinician deems enrollment not clinically appropriate
- Currently enrolled in other investigational drug or device studies that may affect outcomes
- Any implanted or external electrical devices that might interfere with the AeroNova System, including neurological stimulators, cardiac pacemakers, or defibrillators
- Known or suspected pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71103
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
Temple University
Philadelphia, Pennsylvania, United States, 19122
Actively Recruiting
5
Prisma Health
Columbia, South Carolina, United States, 29203
Actively Recruiting
6
University Health Network (UHN)
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
M
Megan O'Toole
CONTACT
S
STARI Study
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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