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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06374225). StuddyBuddy aggregates publicly available trial information.