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Completed
NCT06374225
Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention
Conditions: Critical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: University of Colorado, Denver
Location: University of Colorado Aurora Colorado
Summary
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%).
Eligibility Criteria
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 36 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
Source: ClinicalTrials.gov (NCT06374225). StuddyBuddy aggregates publicly available trial information.