NCT06895148

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,125 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilation

Interventions

Type	Name	Description
DEVICE	New ventilator	The new ventilator order (intervention) was developed using economic behavior theory to decrease the cognitive burden on the ordering provider while enhancing the operability of the order itself. The strategy resulted in a new ventilator order that includes the following changes: 1. Automatic calculation of the PBW based on the most recent height 2. If the height is not available, an order to obtain a height will be generated and the choice of tidal volume will be based on cc/kg PBW 3. Simplify ventilator modes to accurately reflect the standard of care 4. Reduce duplicative information in the monitoring and comments portion of the order 5. Cascade ventilator orders based on mode to enhance visualization.
DEVICE	control ventilator	Current ventilator order used by control hospitals

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-16
• Completion: 2026-07-16
• First posted: 2025-03-26
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study