Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients

May 4, 2026 updated by: University of Colorado, Denver
A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project will be a multi-hospital, cluster randomized study to implement a targeted oxygen saturation (SpO2) range of 90-96% in adult patients receiving mechanical ventilation (MV) using a multimodal educational intervention strategy. Hospital-level randomization to receive the intervention will occur sequentially for a phased roll-out of multimodal education and real-time informatics tools to enhance adherence of the targeted SpO2 range in eligible mechanically ventilated patients. This phased roll-out is achieved through a stepped wedge approach in a one-way crossover design in which all participating hospital ICUs will ultimately implement the intervention, and the timing of the intervention implementation is randomly ordered. The intervention will occur using 4 clusters that switch from control to intervention at 4 pre-determined time points, 1 for each cluster. For each switch, the design incorporates a 2-week transition period for staff education/implementation at each cluster, during which training will be delivered to each participating hospital to improve implementation. The investigators will provide standardized education and materials to local stakeholders for hospital and ICU-level implementation. During the transition period, the cluster cannot be considered as either receiving the structured usual care intervention (education-based intervention) or the unstructured usual care control (current state, no education-based intervention), and thus patients treated in the hospital during that period will not be enrolled or included in the analysis.

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. Data collection for Phase I began 9/1/2024 and will end 9/15/2025.

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 (Phase II). Data collection for Phase II began 3/25/2026 and will end 7/31/2026. 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, Phase II 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

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admission to ICU and requiring invasive mechanical ventilation

Exclusion Criteria:

  • Transferred patients from outside the UCHealth system*:
  • Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy*:
  • Pregnant women:
  • Prisoners
  • Patients receiving mechanical ventilation for less than twelve hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator Free Days (Phase I,II)
Time Frame: 30 Days
The number of days the patient will be free of mechanical ventilation
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
instances of occult hypoxemia (Phase I,II)
Time Frame: 30 days
arterial oxygen saturation below 88% when the Sp02 is greater than 90% among all patients
30 days
ICU free days (Phase I,II)
Time Frame: 90 days
Number of days patients are not in the ICU
90 days
Hospital free days (Phase I, II)
Time Frame: 90 DAYS
number of days patients are not hospitalized
90 DAYS
90 Day in hospital mortality (Phase I, II)
Time Frame: 90 days
Patients that die in the hospital before day 90
90 days
Time to Mortality to day 90 (Phase I,II)
Time Frame: 90 Days
Patients that die within 90 days
90 Days
Oxygen status at discharge (Phase I, II)
Time Frame: 90 days
What if any oxygen the patient is on at discharge
90 days
Incidence of needing high level 02 support (Phase I, II)
Time Frame: 90 days
The number of times that the patients is in need of heated-high flow nasal cannula (HHFNC) / non-invasive positive pressure ventilation (NIPPV)) after extubation
90 days
Discharge disposition (Phase I, II)
Time Frame: 90 days
Place the patient is discharged to
90 days
Changes to mechanical ventilation order set (Phase II)
Time Frame: 4 hours
Quantify the number of changes made to the ventilator order set to attempt to deliver more oxygen to the blood. This will capture FIO2, PEEP, Tidal Volume, Inspiratory Pressure changes as a summary numerical unit of measure.
4 hours
Medication changes (Phase II)
Time Frame: 4 hours
Addition or dose change of a medication to try and eliminate occult hypoxemia will be quantified numerically. The investigators will include diuretics, inhaled vasodilators, corticosteroids, Intravenous sedatives, and intravenous paralytics in this summary statistic.
4 hours
Additional procedures in response to occult hypoxemia (Phase II)
Time Frame: 4 hours
The investigators will quantify the number of additional procedures that may be performed in response to occult hypoxemia. Chest X-ray, Chest CT Scan, arterial blood gas, and placement of arterial catheter procedures will be included in this summary statistic.
4 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of mechanically ventilated time on SpO₂ protocol target (Phase I, II)
Time Frame: 30 days
Reported between index intubation and 30 days later. The SpO₂ protocol target is defined as SpO₂ 90-96% or receiving no oxygen (FiO₂ 0.21 with SpO₂>96%) or maximal oxygen (FiO₂ 1.00, with SpO₂ below 90%) while requiring mechanical ventilation.
30 days
Proportion of participants receiving high levels of oxygen support (FiO₂ >0.80) (Phase I, II)
Time Frame: 30 days
Defined as >2 hours while requiring mechanical ventilation. This includes only the time the patient is in the ICU and receiving any amount of respiratory support (IMV or otherwise).
30 days
Proportion of time at high levels of oxygen support (FiO₂ >0.80) (Phase I, II)
Time Frame: 30 days
Quantified during mechanical ventilation.
30 days
Proportion of time receiving room air oxygen (FiO₂ 0.21) (Phase I, II)
Time Frame: 30 days
Quantified during mechanical ventilation.
30 days
Incidence of documented hypoxic events (SpO₂ <88% OR PaO₂ <60 mmHg) (Phase I, II)
Time Frame: 30 days
Quantified during mechanical ventilation.
30 days
Incidence of documented hyperoxic events (SpO₂ >98% OR PaO₂ >150 mmHg) (Phase I, II)
Time Frame: 30 days
Quantified during mechanical ventilation.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Neil Aggarwal, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

July 8, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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