Clinical trial NCT06374225: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention
Official title: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: O2matic ApS
name: IDTS Medical, Inc.
First posted: 2024-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

Detailed 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.

Eligibility criteria: 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 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)

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

Primary outcomes:
measure: Proportion of time spent within the targeted normoxemia range
timeFrame: 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:
measure: Amount of supplemental oxygen administered
timeFrame: during first 72 hours after randomization
measure: Proportion of time spent in hypoxemia (SpO2<88%)
timeFrame: during first 72 hours after randomization
measure: Proportion of time spent in hyperoxemia (SpO2 >96%)
timeFrame: during first 72 hours after randomization
measure: Time to Room Air
timeFrame: censored at day 28, discharge if before day 28, or death.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: