RECRUITING

STimulation to Activate RespIration

Conditions

ARDS (Moderate or Severe)AHRF Mechanically Ventilated ICU Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-02-28

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06832306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 moderate-to-severe arterial hypoxemia defined by one of: * PaO2:FiO2 ratio \<≤200 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 235%) or * Are receiving inhaled nitric oxide for acute hypoxemia, or * Are being ventilated in the prone position for acute hypoxemia, and 5. Have been mechanically ventilated for AHRF in the current ICU for \<72 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, and 7. Have not spontaneously triggered the ventilator for the previous 2 hours and there is no immediate plan to transition to assisted ventilation.	1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, 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. Severe hemodynamic instability (requiring norepinephrine or epinephrine \> 0.5 mcg/kg/min) 5. Require extracorporeal membrane oxygenation. 6. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles. 7. BMI \>70 kg/m2. 8. 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). 9. Patient expected to transition to fully palliative care within 72 hours of enrollment. 10. Severe liver disease (Child-Pugh Score ≥10) 11. Treating clinician deems enrollment not clinically appropriate. 12. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study. 13. 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. 14. Known or suspected to be pregnant or lactating.

Inclusion Criteria

Exclusion 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 moderate-to-severe arterial hypoxemia defined by one of:
* PaO2:FiO2 ratio \<≤200 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 235%) or
* Are receiving inhaled nitric oxide for acute hypoxemia, or
* Are being ventilated in the prone position for acute hypoxemia, and
5. Have been mechanically ventilated for AHRF in the current ICU for \<72 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, and
7. Have not spontaneously triggered the ventilator for the previous 2 hours and there is no immediate plan to transition to assisted ventilation.

1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, 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. Severe hemodynamic instability (requiring norepinephrine or epinephrine \> 0.5 mcg/kg/min)
5. Require extracorporeal membrane oxygenation.
6. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.
7. BMI \>70 kg/m2.
8. 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).
9. Patient expected to transition to fully palliative care within 72 hours of enrollment.
10. Severe liver disease (Child-Pugh Score ≥10)
11. Treating clinician deems enrollment not clinically appropriate.
12. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.
13. 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.
14. Known or suspected to be pregnant or lactating.

Contacts and Locations

Study Contact

Megan O'Toole

CONTACT

(484) 350-4530

motoole@lungpacer.com

STARI Study

CONTACT

(484) 350-4530

STARIstudy@lungpacer.com

Principal Investigator

Ewan Gohligher, MD, PhD, FRCPC

PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Study Locations (Sites)

Louisiana State University Health Sciences

Shreveport, Louisiana, 71103

United States

Prisma Health

Columbia, South Carolina, 29203

United States

Collaborators and Investigators

Sponsor: Lungpacer Medical Inc.

Ewan Gohligher, MD, PhD, FRCPC, PRINCIPAL_INVESTIGATOR, Toronto General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-28

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

ARDS (Moderate or Severe)
AHRF
Mechanically Ventilated ICU Patients