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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06374225
Other study ID # 23-0866
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date May 1, 2026

Study information

Verified date June 2024
Source University of Colorado, Denver
Contact Erin Anderson
Phone 720-999-8760
Email erin.l.anderson@cuanschutz.edu
Is FDA regulated No
Health authority
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), the investigators 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: the investigators 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. The investigators 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. The investigators 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: The investigators 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 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

Study Design


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.
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