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

NCT06895148 | Recruiting FDA Device

• 1 other identifier: ADHERE-LPV
• Study Type: interventional
• Target: 1,125
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Standard of Care Ventilator

ACTIVE COMPARATOR

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

Experimental Ventilator

EXPERIMENTAL

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

Device: New ventilator

Interventions

New ventilator 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.

Experimental Ventilator

control ventilator DEVICE

Current ventilator order used by control hospitals

Standard of Care Ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and over
• Requires mechanical ventilation

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nick Ingraham, MD, MS

CONTACT

(612) 624-0999; ingra107@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (1)