Critical Illness Clinical Trial
— SAVE-O2 AIOfficial title:
Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)
NCT number | NCT06374225 |
Other study ID # | 23-0866 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2024 |
Est. completion date | May 1, 2026 |
This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 1, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness - Able to be randomized within 24 hours of hospital arrival - Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy) - Signed and dated informed consent from patient or legally authorized representative (LAR) Exclusion Criteria: - Anticipated hospital discharge within 24 hours - Imminent plans to discontinue supplemental oxygen - Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation - Clinical team unwilling or unable to follow the prescribed oxygen titration method in either randomized group - Known prisoner - Known pregnancy - Known contraindicated conditions for use of the PRO100 device: carbon monoxide poisoning, incapable of handling airway secretions, increased methemoglobin, cyanide poisoning, cluster headaches, undrained pneumothorax, sickle cell crisis, paraquat poisoning or a history of bleomycin poisoning, patients for whom the SpO2 signal is not stable |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Oregon Health and Sciences University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | IDTS Medical, Inc., O2matic ApS, United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of time spent within the targeted normoxemia range | The primary endpoint is proportion 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. | 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. | |
Secondary | Amount of supplemental oxygen administered | defined as total estimated oxygen volume during the first 72 hours after randomization. | during first 72 hours after randomization | |
Secondary | Proportion of time spent in hypoxemia (SpO2<88%) | Proportion of time spent in hypoxemia (SpO2 <88%) during the first 72 hours after randomization. | during first 72 hours after randomization | |
Secondary | Proportion of time spent in hyperoxemia (SpO2 >96%) | Proportion of time spent in hyperoxemia (SpO2 >96%) during the first 72 hours after randomization. | during first 72 hours after randomization | |
Secondary | Time to Room Air | defined as the time from hospital presentation to the first episode of no supplemental oxygen (room air), censored at discharge or death. | censored at day 28, discharge if before day 28, or death. |
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