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

NCT06895148 — Not applicable, Recruiting, 1500 participants, University of Minnesota

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT06895148
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Enrollment	1500 (Estimated)
Sponsor	University of Minnesota (Other)
Conditions	Ventilation
Interventions	New ventilator, control ventilator (Device)
Dates	start 2025-07-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-03-26, last updated 2026-09-22
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Standard of Care Ventilator	Active comparator	Device: control 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.
Experimental Ventilator	Experimental	Device: New ventilator	Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order

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.
control ventilator (Device): Current ventilator order used by control hospitals

+Outcome measures

Primary outcomes

lung-protective ventilation [4 hours]: The primary outcome is a binary indicator of lung-protective ventilation (set tidal volume of 8 mL/kg predicted body weight or less) at the first documented set tidal volume at least 4 hours after the start of invasive mechanical ventilation.

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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
* 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.

+Locations (1)

Facility	City	Country	Status
University of Minnesota	Minneapolis, Minnesota	United States	Recruiting