ACTIVE_NOT_RECRUITING

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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%).

Official Title

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

Quick Facts

Study Start:2024-04-29
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06374225

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness
  3. * Able to be randomized within 36 hours of hospital arrival
  4. * Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy)
  5. * Signed and dated informed consent from patient or legally authorized representative (LAR)
  1. * Anticipated hospital discharge within 24 hours
  2. * Imminent plans to discontinue supplemental oxygen
  3. * Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation
  4. * Clinical team unwilling or unable to follow the prescribed oxygen titration method in either randomized group
  5. * Known prisoner
  6. * Known pregnancy
  7. * 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

Contacts and Locations

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Oregon Health and Sciences University
Portland, Oregon, 97239
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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