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Recruiting Not applicable NCT06501118

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

No applicable phase (e.g. observational)
Conditions: Respiratory Failure Acute Hypoxemic Respiratory Failure Acute Hypoxic Respiratory Failure Hypoxemia Hypoxia Hypoxic Respiratory Failure

Sponsor: University of Colorado, Denver

trial.available_in: БГ
Overview
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.
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
Who can participate
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
Interventions
Education
OTHER
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BEHAVIORAL
Locations 1
United States (1)
University of Colorado
Aurora , Colorado
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.09.2024
Completion date
31.07.2026
Registry ID
NCT06501118
Source
clinicaltrials.gov
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