ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation

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.

NCT Number	NCT06895148
Lead Sponsor	University of Minnesota
Conditions	Ventilation
Enrollment	1,125 participants
Start Date	2025-07-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-09