Diaphragm stimulation to improve breathing in ICU patients on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 feasibility trial investigates the effects of diaphragm neurostimulation-assisted ventilation (DNAV) in patients with acute hypoxemic respiratory failure who are on mechanical ventilation. Participants will be randomly assigned to receive either DNAV combined with lung-protective ventilation or lung-protective ventilation alone. The study aims to assess the safety and efficacy of this intervention in improving respiratory function in patients with moderate to severe acute respiratory distress syndrome (ARDS). The trial is multi-center and open-label, allowing for a diverse patient population across different locations.

Why it matters

Who can join: the full rules

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.
11. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.
12. 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.
13. Known or suspected to be pregnant or lactating.

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting
• Louisiana State University Health Sciences
  Shreveport, Louisiana, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Temple University
  Philadelphia, Pennsylvania, United States Recruiting
• Prisma Health
  Columbia, South Carolina, United States Recruiting
• University Health Network (UHN)
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Ewan Goligher, MD, PhD, FRCPC — Toronto General Hospital
• Study coordinator: Megan Cotts
• Email: mcotts@lungpacer.com
• Phone: (612) 986-7172

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transpulmonary Pressure-Guided Ventilation for Right Heart Protection in ARDS

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• How changing PEEP affects breathing drive and effort during pressure‑support ventilation

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• PRE-VAIL: reducing enteral feeding before prone positioning for severe ARDS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.