Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

4 sites in 1 country.

About this study

Official title: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)

Conditions

Critical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes

Being tested

Automated Titration (O2matic)

Keywords

hypoxia, hyperoxia, burn, trauma, acute care surgery, acute respiratory illness, critical illness, supplemental oxygen, oxygenation, SpO2, PaO2, FiO2, normoxia, hypoxemia, hyperoxemia, normoxemia, autonomous, device

Medical subject headings

Critical Illness, Wounds and Injuries, Disease Attributes, Pathologic Processes, Hypoxia, Hyperoxia, Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Automated Titration (O2matic)Device

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Percentage of Time Spent Within the Targeted Normoxemia Range

   The primary endpoint is percentage of time spent within the targeted normoxemia range, defined as an oxygen saturation (SpO2) of 90-96% (target 93%), as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.

   Measured: during first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Apr 2024
2. Study start29 Apr 2024
3. Primary completion7 Dec 2025
4. Study completion9 Jan 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Critical IllnessStudies of the same condition, open and under way.
• More trials run by University of Colorado, DenverThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.