NCT06832306

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2025

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
May 2025Dec 2026

First Submitted

Initial submission to the registry

February 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 9, 2026

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

February 6, 2025

Last Update Submit

January 7, 2026

Conditions

ARDS (Moderate or Severe)AHRFMechanically Ventilated ICU Patients

Outcome Measures

Primary Outcomes (3)

  • Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria

    Within 18 hours of meeting readiness to stimulate criteria

  • Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console)

    30 days

  • Rehabilitation sessions delivered at least once per day on >50% of days when the patient was breathing in assisted (patient-triggered) mechanical ventilation

    30 days

Secondary Outcomes (1)

  • Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group

    30 days

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group subjects will have the Catheter placed percutaneously into the left jugular vein or left subclavian vein. Mapping will identify the electrodes that stimulate the phrenic nerves and enable diaphragm contraction using the AeroNova Console. The stimulation level will be titrated to target a level of diaphragm activation equivalent to resting quiet breathing by adjusting the stimulation frequency and amplitude. Subjects will receive continuous stimulation plus standard of care lung-protective ventilation.

Device: Phrenic Nerve Stimulation

Control

NO INTERVENTION

Standard of Care - Lung-protective ventilation

Interventions

Phrenic Nerve StimulationDEVICE

During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.

Also known as: Diaphragm neurostimulation-assisted ventilation (DNAV)
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • 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

You may not qualify if:

  • 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.
  • Chronic severe liver disease (e.g., Child-Pugh Score ≥10)
  • Treating clinician deems enrollment not clinically appropriate.
  • Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.
  • Any electrical device (implanted or external) that may be prone to interaction with or interference from the AeroNova System, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators.
  • Known or suspected to be pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Louisiana State University Health Sciences

Shreveport, Louisiana, 71103, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Prisma Health

Columbia, South Carolina, 29203, United States

RECRUITING

University Health Network (UHN)

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ewan Goligher, MD, PhD, FRCPC

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan O'Toole

CONTACT

(484) 350-4530motoole@lungpacer.com

STARI Study

CONTACT

(484) 350-4530STARIstudy@lungpacer.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2:1 Randomization treatment to control
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 18, 2025

Study Start

May 28, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 9, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations

US(5)CA(1)