Personalized Ventilator Settings for Patients on ECMO

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07673250
Status
Not Yet Recruiting

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Conditions

  • Acute Respiratory Distress Syndrome (ARDS)
  • Extracorporeal Membrane Oxygenation
  • Respiratory Failure Patients Treated With ECMO
  • Respiratory Failure, ICU
  • Ventilator Induced Lung Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized Positive End-Expiratory Pressure (PEEP) — DEVICE
    The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)

Study Details

While mechanical ventilation can be used to sustain life in those with lung injury, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality as seen in Acute Respiratory Distress Syndrome (ARDS). Using extracorporeal membrane oxygenation (ECMO), the highest level of life support also known as the heart-lung machine, investigators may minimize injury from mechanical ventilation to allow the lungs to heal; however, the optimal ventilator strategies while on ECMO are unknown. This study will evaluate personalized ventilator strategy compared to standard of care ventilation.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Ventilator Settings while on ECMO
    Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and PEEP of 10.
  • Experimental: Personalized PEEP
    Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and a personalized PEEP (intervention)

Primary Outcome Measure

Biomarker outcomes (IL-6 and sRAGE) [ Time Frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Health Jacobs Medical CenterLa JollaCalifornia92037
Mazen F Odish, M.D.
[email protected]
8586577023
Robert L Owens, M.D.
[email protected]

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By research site
UC San Diego Health Jacobs Medical Center· La Jolla, CA

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