Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

April 29, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

May 1, 2026

Conditions
Critical IllnessWounds and InjuryDisease AttributesPathologic Processes
Interventions
DEVICE

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.

Trial Locations (4)

27157

RECRUITING

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

80045

RECRUITING

University of Colorado, Aurora

97239

RECRUITING

Oregon Health and Sciences University, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

O2matic ApS

UNKNOWN

collaborator

IDTS Medical, Inc.

UNKNOWN

lead

University of Colorado, Denver

OTHER