Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
NCT ID: NCT06501118
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3600 participants
INTERVENTIONAL
2024-09-01
2026-07-31
Brief Summary
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Detailed Description
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The investigators define a targeted SpO2 range (90-96%), PaO2 (60-100 mmHg) target based on thresholds defined in recent published work that incorporates expert opinions from the field and includes consensus among critical care COGG members that represent UCHealth hospitals throughout the North, South, and Metro regions as well as the site locations at which the intervention is proposed to occur. The oxygen target range will be defined by an oxygen saturation (SpO2) 90-96%, and when arterial blood gases are available, an arterial oxygen pressure (PaO2) 60-100 mmHg. The intervention will start when patients requiring mechanical ventilation arrive to an ICU in a participating hospital and the intervention will continue for any period of invasive mechanical ventilation required during ICU stay. A project goal is to achieve adherence to \>95% of eligible patient-hours spent in the target SpO2 range, excluding time on FiO2 30% when above SpO2 96% or time on FiO2 100% when below SpO2 90%. Each hospital site will contribute pre-implementation (control) and post-implementation (intervention) data, with the start of the consensus-based intervention period defined by the randomized timing in the stepped wedge design.
Patients will be ventilated with a standardized UCHealth-wide mechanical ventilation order-set to achieve these SpO2 and PaO2 goals. These order-sets included the ARDSNetwork low- and high-PEEP/FiO2 arms, as well as developed protocols for alternative modes of ventilation, such as APRV which can be used at the provider teams' discretion.
Once all hospital clusters have transitioned to the intervention phase, a nested study will commence that involves a patient-level intervention for mechanically ventilated patients experiencing residual occult hypoxemia among participating UCHealth ICUs. These patients will be identified automatically in the EHR (EPIC) by comparing the SaO2 from an ABG laboratory procedure to contemporaneous SpO2 flowsheet row values and then will be randomized 1:1 to either an active or silent notification delivered in real-time to members of the provider team alerting them to each OH instance, with a 12-hour notification lockout. A unique research study order will be created in EPIC for this nested study to facilitate tracking of outcomes for patients randomized to silent and active notification arms in coordination with a health data compass analyst (HDC).
Educational interventions will include:
1. Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
2. EPIC-generated push notification to (1) alert providers in real-time to the presence of OH in their patient with a time-stamp based on SpO2 and SaO2 values compared from vital signs and arterial blood gas oxygen saturation respectively, and (2) inform them of the potential associations of OH with worse outcomes in similar, critically ill patients, and (3) choices for potential changes to management, including an "acknowledge only" option
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Educational intervention
SP02 target ranges will be 90-96%. Education about the specific oxygen targets will be provided to the clinical teams. Real time feedback on adherence to the Sp02 target range will be provided by virtual respiratory therapists.
Education
1\) Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
Educational intervention Epic alert
An education-based intervention that also focuses on mitigating Occult Hypoxemia in mechanically ventilated patients, and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic as
1. alert (notification) the providers of sustained occult hypoxemia or
2. silent alert The investigators are observing physician behavior in response to alerting them that a patient has occult hypoxemia via an Epic alert.
Epic notification alert
An education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as
1. alert (notification) the providers of sustained occult hypoxemia
2. silent alert
Interventions
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Education
1\) Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
Epic notification alert
An education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as
1. alert (notification) the providers of sustained occult hypoxemia
2. silent alert
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy\*:
* Pregnant women:
* Prisoners
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Neil Aggarwal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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References
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Other Identifiers
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24-0065
Identifier Type: -
Identifier Source: org_study_id