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STimulation to Activate RespIration | Clinical Trials | Clareo Health

RECRUITINGNA

STimulation to Activate RespIration

A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure

NCT06832306•Lungpacer Medical Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, 18 years or older, and
•2. Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and
•3. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and
•4. Have arterial hypoxemia defined by one of:
•* PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or
•* In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately preceding eligibility assessment (this correlates to an upper limit of SpO2:FiO2 ratio of 316%) or
•* Are receiving pulmonary vasodilators for acute hypoxemia, or
•* Are being ventilated in the prone position for acute hypoxemia, and
•5. Have been mechanically ventilated for AHRF in the ICU for \<96 hours at the time of enrolment, and
•6. Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician

Exclusion Criteria

•1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.
•2. Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis).
•3. Broncho-pleural fistula at the time of eligibility assessment.
•4. Require extracorporeal membrane oxygenation.
•5. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
•6. BMI \>70 kg/m2.
•7. 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).
•8. Patient expected to transition to fully palliative care within 72 hours of enrollment.
•9. Chronic severe liver disease (e.g., Child-Pugh Score ≥10)
•10. Treating clinician deems enrollment not clinically appropriate.
+3 more criteria

Locations (6)

University of California San Diego

La Jolla, California, United States

Louisiana State University Health Sciences

Shreveport, Louisiana, United States

Cleveland Clinic

Cleveland, Ohio, United States

Temple University

Philadelphia, Pennsylvania, United States

Prisma Health

Columbia, South Carolina, United States

University Health Network (UHN)

Toronto, Ontario, Canada

Key Dates

Start Date

May 28, 2025

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

ARDS (Moderate or Severe)AHRFMechanically Ventilated ICU Patients

Interventions

Phrenic Nerve Stimulation

DEVICE

Contacts

Megan O'Toole

CONTACT

(484) 350-4530 motoole@lungpacer.com

STARI Study

CONTACT

(484) 350-4530 STARIstudy@lungpacer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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