300
Participants
Start Date
April 29, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
May 1, 2026
Automated Titration (O2matic)
The patient will receive supplemental oxygen titrated using an autonomous oxygen titration device. The patient will be monitored and vital signs documented by the site's usual SpO2 assessments, but oxygen titration will occur automatically through the O2matic PRO100 device during the intervention period, unless there is a safety concern. The SpO2 range programmed into the PRO100 is 92-94%. The acceptable SpO2 range for the protocol is 90-96%. If a patient requires \>15lpm or other signs of advancing respiratory failure, they will be taken off the autonomous oxygen and transitioned to higher flow oxygen devices or mechanical ventilation per usual clinical care. If the patient is not receiving any supplemental oxygen per the autonomous titration, the clinical team may remove the oxygen delivery device from the patient, but the patient should remain connected to the PRO100 for the duration of the intervention period for data collection and to monitor for new supplemental oxygen needs.
RECRUITING
Atrium Health Wake Forest Baptist Medical Center, Winston-Salem
RECRUITING
Vanderbilt University Medical Center, Nashville
RECRUITING
University of Colorado, Aurora
RECRUITING
Oregon Health and Sciences University, Portland
Collaborators (1)
United States Department of Defense
FED
O2matic ApS
UNKNOWN
IDTS Medical, Inc.
UNKNOWN
University of Colorado, Denver
OTHER