Actively Recruiting
A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
Led by Lungpacer Medical Inc. · Updated on 2026-01-09
30
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach for patients with acute hypoxemic respiratory failure (AHRF) who require mechanical ventilation. This trial focuses on patients with lung injury, including those meeting criteria for acute respiratory distress syndrome (ARDS). The study is a multi-center, randomized, controlled, open-label Phase 2 feasibility trial designed to assess the use of temporary transvenous diaphragm neurostimulation in these critically ill patients. Participants are randomly assigned in a 2:1 ratio to receive either diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System combined with standard lung-protective ventilation, or lung-protective ventilation alone. In the treatment group, a catheter is placed into a central vein to stimulate the phrenic nerves and activate the diaphragm in sync with the ventilator breaths. The stimulation level is adjusted to mimic resting breathing. The control group receives standard lung-protective ventilation without stimulation. During the study, patients are monitored for successful device insertion and stimulation initiation within 18 hours of readiness. Researchers track how often stimulation is delivered during ventilator breaths and the frequency of rehabilitation sessions over 30 days. Safety is assessed by recording any unexpected serious adverse device events. The study involves continuous recordings from the AeroNova Console and clinical assessments throughout the treatment period to evaluate feasibility and safety of this novel ventilation support method.
CONDITIONS
Brief 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 who can provide consent
- Acute onset of new respiratory symptoms or dysfunction within 2 weeks before needing respiratory support
- Arterial hypoxemia defined by 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, or receiving pulmonary vasodilators, or ventilated in the 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 48 hours or more after enrollment in clinician's opinion
You will not qualify if you...
- Hypoxemia mainly due to COPD exacerbation, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism
- Underlying chronic lung disease that may hinder recovery, such as COPD or pulmonary fibrosis
- Broncho-pleural fistula at eligibility assessment
- Need for extracorporeal membrane oxygenation
- Pre-existing neurological, neuromuscular, or muscular disorder or known phrenic nerve injury affecting respiratory muscles
- Body mass index over 70 kg/m2
- Contraindications to left jugular or subclavian vein catheterization (e.g., infection, stenosis, thrombophlebitis, existing cannula)
- Expected transition to palliative care within 72 hours of enrollment
- Chronic severe liver disease (Child-Pugh Score 6510)
- Clinician deems enrollment not appropriate
- Currently enrolled in another investigational drug or device study affecting outcomes
- Any implanted or external electrical device that may interfere with AeroNova System, including pacemakers and neurological stimulators
- Known or suspected pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days or until discontinuation of mechanical ventilation
Participants receive either temporary transvenous diaphragm neurostimulation with standard lung-protective ventilation or standard lung-protective ventilation alone while mechanically ventilated.
Continuous monitoring during mechanical ventilation with regular assessments
Duration - Up to 30 days after treatment
Participants are monitored for safety and rehabilitation outcomes after treatment ends.
Approximately 1 to 2 follow-up visits
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
S
STARI Study
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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