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Search / Trial NCT06792617

Exercise Rehabilitation in Patients With Severe Cardiopulmonary Dysfunction on Extracorporeal Life Support

Launched by INSTITUTE FOR EXTRACORPOREAL LIFE SUPPORT · Jan 21, 2025

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

Extracorporeal Membrane Oxygenation (Ecmo) Rehabilitation Exercise Program

ClinConnect Summary

I.Introduction

The long-term consequences of severe cardiac and/or lung dysfunction include: the increased use of sedation, increased parameters on the ventilator, and incidence of delirium. These sequelae are all associated with prolonged bed rest and immobility, which causes severe loss of muscle mass and bone density. Significant loss of muscle and bone causes patients to be at risk for muscle weakness, osteoporosis, and lowered endurance. Extracorporeal membrane oxygenation (ECMO) is a strategy used to mitigate severe cardiac and/or lung dysfunction. Briefly, during ECMO, blood passes ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria--
  • 1. Age \>or equal to 18 years old
  • 2. On ECMO (VV and/or VA) for cardiopulmonary dysfunction/failure
  • 3. Admitted to Lung Recovery Intensive Care Unit (LRICU) or Cardiovascular Intensive Care Unit (CVICU).
  • 4. Richmond Agitation and Sedation Scale (RASS) greater than or equal to a score of -2 or greater.
  • Exclusion Criteria--
  • 1. Hemodynamically unstable as determined by clinical care team (including but not limited to: oxygen saturation \<90%, below target range of mean arterial pressure despite vasoactive or mechanical support, prone positioning, use of mechanical assist device (such as the intra-aortic balloon pump \[IABP\] or ventricular assist device \[VAD\]), active management of intracranial hypertension with abnormal intracranial pressure, spinal precautions, uncontrolled seizures, unstable major fracture, large open surgical wound, known controlled active bleeding).
  • 2. Unable to utilize the VitalGo Total Lift BedTM (TLB, Catalog No. V5, Miramar FL) (e.g., height restrictions \[\>228 cm\], weight restrictions \[\>425 lbs\])
  • 3. Pregnant or breast feeding.
  • 4. Anticipated transfer to another hospital within 72 hours.
  • 5. Not anticipated to survive more than 24 hours.
  • 6. Unable to obtain informed consent from either patient or legally authorized representative (LAR).
  • 7. Patients in the ICU but not on ECMO upon enrollment.
  • 8. Patients actively awaiting transplant (heart/lung) without potential for weaning from ECMO.

About Institute For Extracorporeal Life Support

The Institute for Extracorporeal Life Support is a leading clinical research organization dedicated to advancing the field of life support technologies and therapies. Focused on innovative solutions for patients requiring advanced circulatory and respiratory support, the Institute conducts rigorous clinical trials to evaluate the safety and efficacy of extracorporeal life support systems. With a commitment to improving patient outcomes, the Institute collaborates with healthcare professionals, researchers, and industry partners to drive evidence-based advancements in critical care medicine, ultimately enhancing the quality of life for patients facing severe cardiac and respiratory failure.

Locations

San Antonio, Texas, United States

Patients applied

0 patients applied

Trial Officials

Linda E Sousse, PhD, MBA

Principal Investigator

Institute for Extracorporeal Life Support

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported