Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

NCT06374225 | Completed DMC FDA Device

• 1 other identifier: 23-0866
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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%).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Amount of supplemental oxygen administered

  during first 72 hours after randomization

• Proportion of time spent in hypoxemia (SpO2<88%)

  during first 72 hours after randomization

• Proportion of time spent in hyperoxemia (SpO2 >96%)

  during first 72 hours after randomization

• Time to Room Air

  censored at day 28, discharge if before day 28, or death.

Study Arms (2)

Usual Care (Manual Titration)

NO INTERVENTION

Patients randomized to the usual care arm will receive usual care, manual oxygen titration, removal of supplemental oxygen, and escalation per hospital protocol, based on the site's usual SpO2 assessments. The SpO2 monitor for the O2matic PRO100 will also be connected to the patient in observation mode for data collection purposes only (not used for titration decisions).

Intervention (Automated Titration)

EXPERIMENTAL

Patients randomized to the intervention arm will receive supplemental oxygen via nasal cannula (recommended up to 6 lpm) or face mask (recommended up to 15 lpm) and will have supplemental oxygen titrated using an autonomous oxygen titration system for the first 72 hours after randomization, or hospital discharge (whichever sooner).

Device: Automated Titration (O2matic)

Interventions

Automated Titration (O2matic) DEVICE

The patient will receive supplemental oxygen titrated using an autonomous oxygen titration device. The patient will be monitored and vital signs documented by the site's usual SpO2 assessments, but oxygen titration will occur automatically through the O2matic PRO100 device during the intervention period, unless there is a safety concern. The SpO2 range programmed into the PRO100 is 92-94%. The acceptable SpO2 range for the protocol is 90-96%. If a patient requires \>15lpm or other signs of advancing respiratory failure, they will be taken off the autonomous oxygen and transitioned to higher flow oxygen devices or mechanical ventilation per usual clinical care. If the patient is not receiving any supplemental oxygen per the autonomous titration, the clinical team may remove the oxygen delivery device from the patient, but the patient should remain connected to the PRO100 for the duration of the intervention period for data collection and to monitor for new supplemental oxygen needs.

Intervention (Automated Titration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Department of Defense: collaborator
• University of Colorado, Denver: lead
• O2matic ApS: collaborator
• IDTS Medical, Inc.: collaborator

Study Sites (4)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Douin DJ, Rice JD, Xiao M, Beaty L, Guo C, Withers C, Sullivan A, Anderson EL, Cheng AC, Banasiewicz MK, Semler MW, Lloyd BD, Maiga A, Gibbs KW, Stettler GR, Khan A, Sally MB, Wright FL, Aggarwal N, Bebarta VS, Ginde AA; SAVE-O2 AI Investigators. Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol. BMJ Open. 2026 Jan 28;16(1):e110739. doi: 10.1136/bmjopen-2025-110739.

  PMID: 41605593 DERIVED

MeSH Terms

Conditions

Critical Illness; Wounds and Injuries; Disease Attributes; Pathologic Processes; Hypoxia; Hyperoxia; Burns

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: April 29, 2024
• Primary Completion: December 7, 2025
• Study Completion: January 9, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)