Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 educationimplementation 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-PEEPFiO2 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
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-PEEPFiO2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None