Clinical trial NCT06895148: ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
Official title: ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 1125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.

The intervention will be tested within the MHFV health system which includes a 10-hospital network admitting over 2,500 mechanically ventilated patients annually.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a cluster randomized trial across 10 hospitals, stratified by hospital size (hospitals with greater than 100 mechanically ventilated patients a year will be classified as large, while those with 100 or fewer will be classified as small). Randomization will occur at the hospital level, ensuring an even distribution of large and small hospitals between study arms. Hospitals assigned to the intervention group will implement an EHR-based strategy designed to enhance adherence to lung-protective ventilation (LPV) for a 9-month intervention period, after which the strategy will be rolled out to all hospitals. The intervention focuses on modifying the ventilator order within the Electronic Health Record (EHR) to encourage default settings aligned with LPV principles. This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* Requires mechanical ventilation

Exclusion Criteria:

* The patient opted out of research
* The mode ordered does not require a set tidal volume
* Requires ECMO prior to ICU admission
* Data during the use of ECMO
* Hospitalization was for an elective surgery
* The duration of mechanical ventilation was less than 12 hours (these are not the patients that would benefit from LPV)
* Admission code documentation of Do Not Intubate. While rare, in situations where a patient was intubated but whose preferences are contradictory to the current care, mechanical ventilation is managed differently while undergoing goals of care conversations.
* Height was documented as less than 4 feet given the PBW formula was not validated below this height.

Primary outcomes:
measure: lung-protective ventilation
timeFrame: 4 hours
Secondary outcomes:
measure: Rate (hours) with set tidal volume < 6cc/kg PBW
timeFrame: 72 hours
measure: Rate (hours) exposure to >8 cc/kg PBW
timeFrame: 72 hours
measure: Rate (hours) exposure to >10 cc/kg PBW
timeFrame: 72 hours
measure: Time to adhere to ≤ 8 cc/kg per day: Of all patients set to >8 cc/kg per day, how long did it take for the patient to receive ≤ 8 cc/kg per day?
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
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