Phrenic Nerve Stimulation for Acute Respiratory Distress Syndrome

(STARI Trial)

Recruiting at 5 trial locations

Overseen By STARI Study

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lungpacer Medical Inc.

Disqualifiers: COPD, Pulmonary fibrosis, Severe liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with serious lung problems who require breathing machines. The study tests a device called the AeroNova System, which stimulates the diaphragm (the main muscle used for breathing) to determine if it can enhance breathing for those with acute respiratory distress syndrome (ARDS). Participants will receive either this new treatment alongside standard lung care or just the standard lung care. Individuals who have developed new breathing problems within the last two weeks, struggle to get enough oxygen even with a ventilator, and are expected to need mechanical ventilation for at least two more days might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future treatments for serious lung conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AeroNova System is safe for phrenic nerve stimulation?

Research shows that the AeroNova System, which aids breathing by stimulating the phrenic nerve, is generally well-tolerated. Previous studies have demonstrated potential benefits, such as reducing ventilator days and decreasing the need to reinsert a breathing tube.

While researchers are testing the system for safety and effectiveness in people with acute respiratory distress syndrome (ARDS), past findings suggest it has manageable side effects. By stimulating the phrenic nerve, the system helps the diaphragm, the main muscle for breathing, to move. This could help prevent lung injuries caused by ventilators.

Overall, initial findings are positive, but more research is needed to fully understand its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AeroNova System for treating Acute Respiratory Distress Syndrome (ARDS) because it offers a novel approach by stimulating the phrenic nerves. Unlike the standard care for ARDS, which typically involves lung-protective ventilation, AeroNova uses a catheter to directly activate the diaphragm through electrical stimulation. This method aims to mimic natural breathing, potentially reducing the strain on the lungs and improving respiratory function. By directly engaging the diaphragm, the AeroNova System could enhance breathing efficiency and offer an innovative alternative to traditional mechanical ventilation.

What evidence suggests that the AeroNova System is effective for acute respiratory distress syndrome?

Research has shown that stimulating the phrenic nerve with systems like the AeroNova can improve breathing in patients with Acute Respiratory Distress Syndrome (ARDS). In this trial, participants in the treatment arm will receive phrenic nerve stimulation using the AeroNova System. This system has helped patients come off ventilators more quickly and with fewer complications. Studies indicate it can reduce diaphragm damage during the use of breathing machines, which is crucial for lung protection. Early results suggest that this method helps the diaphragm work in sync, potentially preventing further lung damage from the ventilator. Overall, evidence supports its potential to enhance breathing and recovery for patients with ARDS. ^{1 2 3 5 6}

Who Is on the Research Team?

Ewan Gohligher, MD, PhD, FRCPC

Principal Investigator

Toronto General Hospital

Are You a Good Fit for This Trial?

This trial is for adults (18+) in the ICU who need mechanical ventilation due to severe lung issues like ARDS. They must have had acute respiratory symptoms within the last two weeks and be expected to require ventilation for at least 48 hours post-enrollment. Those not triggering the ventilator spontaneously for 2 hours prior and without plans to switch to assisted breathing can join.

Inclusion Criteria

My doctor thinks I will need help breathing with a machine for at least 2 days after joining.

I haven't needed help breathing from a machine in the last 2 hours.

I started having new breathing problems within the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diaphragm neurostimulation-assisted ventilation using the AeroNova System plus lung-protective ventilation or lung-protective ventilation alone

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AeroNova System

Trial Overview The study tests phrenic nerve stimulation using the AeroNova System alongside standard lung-protective ventilation against just lung-protective ventilation. It's a Phase 2 trial where patients are randomly assigned in a ratio of 2:1 to either treatment or control groups.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Standard of Care - Lung-protective ventilation

Who Is Running the Clinical Trial?

Lungpacer Medical Inc.

Lead Sponsor

Trials

8

Recruited

440+

Published Research Related to This Trial

A new minimally invasive method for repositioning coronary sinus electrodes in patients with phrenic nerve stimulation (PNS) after cardiac resynchronization therapy was found to be safe and effective, with no pericardial effusion detected post-operation.

In a study of nine patients, the procedure successfully eliminated PNS in most cases, with stable pacing parameters maintained during a follow-up period of about 7.7 months, indicating a reduced burden on patients compared to traditional repositioning methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal invasive coronary sinus lead reposition technique for the treatment of phrenic nerve stimulation. Szilágyi, S., Merkely, B., Zima, E., et al.[2014]

Phrenic nerve stimulation (PNS) significantly protects against diaphragm dysfunction caused by mechanical ventilation (MV) in a study involving 21 rats, restoring diaphragm function and counteracting negative gene expression changes.

While mechanical ventilation led to impaired diaphragm contractility and reduced levels of insulin-like growth factor-1 (IGF-1), PNS was able to reverse these effects, suggesting a potential therapeutic role for PNS in patients requiring mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phrenic nerve stimulation protects against mechanical ventilation-induced diaphragm dysfunction in rats. Yang, M., Wang, H., Han, G., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-2-ards-moderate-or-severe-1-2025-1b797

Phrenic Nerve Stimulation for Acute Respiratory Distress ... Phrenic nerve stimulation, similar to the AeroNova System, has been shown to help patients with breathing issues by stimulating the diaphragm, allowing them to ...

2. lungpacer.com lungpacer.com/lungpacer-publishes-data-in-communications-medicine-indicating-that-lungpacer-aeronova-therapy-restores-brain-activity-connectivity-and-synchronization-in-sedated-mechanically-ventilated-patients-wi/

Lungpacer publishes data in Communications Medicine ... The AeroPace System is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11573254/

Transvenous phrenic nerve stimulation reduces diaphragm ... Transvenous phrenic nerve stimulation reduces diaphragm injury during controlled mechanical ventilation in a preclinical model of ARDS · Abstract. Patients with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06572280

Non-invasive Phrenic Nerve Stimulation in ARDS Patient Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06832306

STimulation to Activate RespIration - UCSD Clinical Trials This Acute Respiratory Distress Syndrome and AHRF study at UCSD is now recruiting people ages 18 years and up.

6. lungpacer.com lungpacer.com/lungpacer-to-showcase-the-potential-of-novel-technologies-to-improve-lung-heart-and-brain-health-in-ventilated-patientskevin-kearney-joins-lungpacer-medical-as-chief-commercial-officer/

Lungpacer to Showcase the Potential of Novel ... The company's breakthrough FDA-approved AeroPace System uses periodic neurostimulation to strengthen the diaphragm, helping patients breathe ...