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.

Study Overview

• Status: Recruiting
• Conditions: Ventilation
• Intervention / Treatment: Device: control ventilator; Device: New ventilator

• Study Type: Interventional
• Enrollment (Estimated): 1125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick Ingraham, MD, MS; Phone Number: (612) 624-0999; Email: ingra107@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Nick Ingraham, MD, MS; Phone Number: 612-624-0999; Email: ingra107@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Ventilator; Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to the current ventilator order that is used across the health system.	Device: control ventilator; Current ventilator order used by control hospitals
Experimental: Experimental Ventilator; Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order	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: Automatic calculation of the PBW based on the most recent height; 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; Simplify ventilator modes to accurately reflect the standard of care; Reduce duplicative information in the monitoring and comments portion of the order; Cascade ventilator orders based on mode to enhance visualization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung-protective ventilation	The primary outcome is a binary indicator of lung-protective ventilation (ventilator set at ≤ 8 cc/kg) at the first documented set tidal volume after 4 hours.	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate (hours) with set tidal volume < 6cc/kg PBW	72 hours
Rate (hours) exposure to >8 cc/kg PBW	72 hours
Rate (hours) exposure to >10 cc/kg PBW	72 hours
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?	72 hours

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ADHERE-LPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No