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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3,600
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.
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
University of Colorado
Aurora, Colorado, United States
RECRUITINGVentilator Free Days (Phase I,II)
The number of days the patient will be free of mechanical ventilation
Time frame: 30 Days
instances of occult hypoxemia (Phase I,II)
arterial oxygen saturation below 88% when the Sp02 is greater than 90% among all patients
Time frame: 30 days
ICU free days (Phase I,II)
Number of days patients are not in the ICU
Time frame: 90 days
Hospital free days (Phase I, II)
number of days patients are not hospitalized
Time frame: 90 DAYS
90 Day in hospital mortality (Phase I, II)
Patients that die in the hospital before day 90
Time frame: 90 days
Time to Mortality to day 90 (Phase I,II)
Patients that die within 90 days
Time frame: 90 Days
Oxygen status at discharge (Phase I, II)
What if any oxygen the patient is on at discharge
Time frame: 90 days
Incidence of needing high level 02 support (Phase I, II)
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
Time frame: 90 days
Discharge disposition (Phase I, II)
Place the patient is discharged to
Time frame: 90 days
Changes to mechanical ventilation order set (Phase II)
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.
Time frame: 4 hours
Medication changes (Phase II)
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.
Time frame: 4 hours
Additional procedures in response to occult hypoxemia (Phase II)
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.
Time frame: 4 hours
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