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

NCT ID: NCT06895148

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-16

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.

Conditions

Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

control ventilator

Intervention Type: DEVICE

Current ventilator order used by control hospitals

Experimental Ventilator

Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order

Group Type: EXPERIMENTAL

New ventilator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

control ventilator

Current ventilator order used by control hospitals

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nick Ingraham, MD, MS

Role: CONTACT

ingra107@umn.edu

(612) 624-0999

Facility Contacts

Nick Ingraham, MD, MS

Role: primary

ingra107@umn.edu

612-624-0999

Other Identifiers

ADHERE-LPV

Identifier Type: -

Identifier Source: org_study_id