272
Participants
Start Date
February 15, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
March 31, 2026
Breath synchronized abdominal FES
Active abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
Sham breath synchronized abdominal FES
Sham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
University of Pittsburgh, Pittsburgh
Vanderbilt University Medical Center, Nashville
University of Cincinnati, Cincinnati
University of Iowa, Iowa City
Edward Hines, Jr. VA Hospital, Hines
Loyola University, Maywood
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
Memorial Hermann, Houston
Providence Regional Medical Center, Everett
Tufts Medical Center, Boston
MD Anderson Cancer Center, Houston
Monash Medical Centre, Clayton
Nepean Hospital, Kingswood
St. George Hospital, Kogarah
Prince of Wales Hospital, Randwick
Royal North Shore Hospital, St Leonards
Pitié-Salpêtrière University Hospital, Paris
Jeroen Bosch Ziekenhuis (JBZ), 's-Hertogenbosch
Canisius Wilhelmina Ziekenhuis (CWZ), Nijmegen
Radboud University Medical Center, Nijmegen
Erasmus Medical Center, Rotterdam
Lead Sponsor
United States Department of Defense
FED
Liberate Medical
INDUSTRY