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NCT07673250
Personalized Ventilator Settings for Patients on ECMO
Conditions: Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation, Respiratory Failure Patients Treated With ECMO, Respiratory Failure, ICU, Ventilator Induced Lung Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: University of California, San Diego
Location: UC San Diego Health Jacobs Medical Center La Jolla California
Summary
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.
Eligibility Criteria
1. History of Lung or Cardiac Transplantation, or definite bridge to transplantation
2. Patient is not committed to full support
3. Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade)
4. Inability to get informed consent from the patient or legally authorized representative (LAR)
5. Patients with contraindications to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.
a. Contraindications include recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement, or severe coagulopathy.
6. Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician.
7. Patients who are pregnant or prisoners.
8. Has been on V-V ECMO \> 72 hours.
Source: ClinicalTrials.gov (NCT07673250). StuddyBuddy aggregates publicly available trial information.