Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Description

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%).

Conditions

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

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Study Overview

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Study Details

Study overview

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%).

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

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Condition
Critical Illness
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Portland

Oregon Health and Sciences University, Portland, Oregon, United States, 97239

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Study Record Dates

2026-05-01