Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Critical Illness Clinical Trial

— SAVE-O2 AI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374225
• Other study ID #: 23-0866
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Erin Anderson
• Phone: 720-999-8760
• Email: erin.l.anderson[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Description:

Ensuring adequate oxygenation is a primary goal in surgical and medical patients to treat and prevent morbidity associated with hypoxemia. However, excessive oxygen administration resulting in hyperoxemia is common, leading to unnecessary utilization of supplemental oxygen, which is a particularly limited resource in austere settings. Building on the previous Strategy to Avoid Excessive Oxygen (SAVE-O2) clinical trials1 (Trauma: NCT045349559; Burn: NCT04534972), we seek to determine effective strategies to implement a targeted normoxemia approach to avoid both hyperoxemia and hypoxemia and reduce supplemental oxygen use, using the PRO100 closed loop/autonomous oxygen system. This research is critical for both military and civilian care settings in determining the effectiveness of an autonomous oxygen system to use to 1) reduce harm associated with both hypoxemia and hyperoxemia and 2) reduce excess use of oxygen. Objectives: We propose the following two objectives: Determine the effectiveness of an autonomous oxygen titration system to improve normoxemia and reduce hypoxemia and hyperoxemia in acutely injured and ill patients receiving supplemental oxygen. We will compare patient-hours spent in normoxemia (SpO2 90-96%), hypoxemia (SpO2 <88%), and hyperoxemia (SpO2 >96%) among patients randomized to autonomous vs manual oxygen titration. Determine the impact of an autonomous oxygen titration system on overall utilization of supplemental oxygen. We will compare the total volume of supplemental oxygen administered to patients randomized to autonomous vs manual oxygen titration during the 72-hour intervention period. Hypothesis: We hypothesize that the use of an autonomous oxygen titration system will be more effective at maintaining normoxemia and reducing time spent in hypoxemia/hyperoxemia than standard manual titration in non-mechanically ventilated patients and will reduce the overall use of supplemental oxygen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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)

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Automated Titration (O2matic)
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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	IDTS Medical, Inc., O2matic ApS, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of supplemental oxygen administered	defined as total estimated oxygen volume during the first 72 hours after randomization.	during first 72 hours after randomization
Secondary	Proportion of time spent in hypoxemia (SpO2<88%)	Proportion of time spent in hypoxemia (SpO2 <88%) during the first 72 hours after randomization.	during first 72 hours after randomization
Secondary	Proportion of time spent in hyperoxemia (SpO2 >96%)	Proportion of time spent in hyperoxemia (SpO2 >96%) during the first 72 hours after randomization.	during first 72 hours after randomization
Secondary	Time to Room Air	defined as the time from hospital presentation to the first episode of no supplemental oxygen (room air), censored at discharge or death.	censored at day 28, discharge if before day 28, or death.