Clinical trial NCT06501118: Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Official title: Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Acute Hypoxemic Respiratory Failure
Acute Hypoxic Respiratory Failure
Hypoxemia
Hypoxia
Hypoxic Respiratory Failure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

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. Virtual respiratory therapist (vRT) - directed real-time feedback on adherence to the SpO2 target range as a part of the mechanical ventilation order-set embedded in UCHealth EHR (EPIC).

Eligibility criteria: 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

Primary outcomes:
measure: Ventilator Free Days
timeFrame: 30 Days
Secondary outcomes:
measure: instances of occult hypoxemia
timeFrame: 30 days
measure: ICU free days
timeFrame: 90 days
measure: Hospital free days
timeFrame: 90 DAYS
measure: 90 Day in hospital mortality
timeFrame: 90 days
measure: Time to Mortality to day 90
timeFrame: 90 Days
measure: Oxygen status at discharge
timeFrame: 90 days
measure: Incidence of needing high level 02 support
timeFrame: 90 days
measure: Discharge disposition
timeFrame: 90 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Neil Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
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