Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation for Weaning from Mechanical Ventilation (PREVENT)
Abstract
Worldwide every day, millions of patients are cared for in intensive care units (ICUs). About one-third of these patients need mechanical ventilation to help them breathe. Mechanical ventilation often causes weakening of the breathing muscle. In turn, weakness of the breathing muscles increases the length of time that a patient requires mechanical ventilation. Long periods of mechanical ventilation cause additional illness and increase the risk of death. Unfortunately, there are currently no treatments that can reduce breathing muscle weakness in patients who are receiving mechanical ventilation. This research study will test a new medical device called the VentFree Respiratory Muscle Stimulator that uses a technique called abdominal functional electrical stimulation (FES). Abdominal FES is a non-invasive technique that applies small electrical pulses to the breathing muscles to cause them to contract while the patient is breathing out. The device is used for 30 minutes, twice per day while a patient is receiving mechanical ventilation. We have previously shown in a small group of patients that this device may reduce the number of days a patient needs mechanical ventilation and the number of days spent in the ICU. In this new research study, one group of patients will be treated with the VentFree stimulator and another group with a device that replicates the stimulator but does not cause the muscles to contract. The results of this study will enable us to determine whether abdominal FES is successful at helping patients come off mechanical ventilation. This research study addresses the Respiratory Health Topic Area and the following Area of Encouragement: Development and/or testing of novel and/or innovative treatments including precision medicine approaches, to prevent, or delay the progression of, acute lung injury (ALI)/acute respiratory distress syndrome (ARDS). This research study has been designed so that its results will apply to a wide range of critically ill patients receiving mechanical ventilation. If this research study is successful, abdominal FES will be the first non-invasive treatment proven to improve breathing muscle strength and to reduce duration of mechanical ventilation in the ICU. By reducing the duration of mechanical ventilation, we expect that fewer critically ill patients will develop additional problems and fewer of them will die while in the ICU or after discharge. We also expect that patients’ quality of life will be improved after discharge from the ICU. The successful completion of this research study will also support U.S. Food and Drug Administration (FDA) clearance of the VentFree stimulator. This will allow abdominal FES to be quickly and widely introduced into clinical care. We expect that abdominal FES will become part of the standard of care for critically ill patients who would otherwise need prolonged mechanical ventilation.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211123
Entities
People
- Angus Mclachlan
Organizations
- United States Army