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

Not Applicable

Not yet recruiting

• Conditions: Ventilation

• Registration Number: NCT06895148
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Study Start: 2025-04-16
• Primary Completion: 2026-07-16
• Study Completion: 2026-07-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
long-protective ventilation indicator	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
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