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

University of Minnesota (UMN)

Status: Enrolling

Conditions: Ventilation

Treatments: Device: New ventilator; Device: control ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT06895148

ADHERE-LPV

Details and patient eligibility

About

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.

Enrollment: 1,125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,125 participants in 2 patient groups

Standard of Care Ventilator

Active Comparator group

Description:

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.

Treatment:

Device: control ventilator

Experimental Ventilator

Experimental group

Description:

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

Treatment:

Device: New ventilator