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

Overview

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.

Interventions

• Device 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
• Device control ventilator
  Current ventilator order used by control hospitals

Primary outcome measures

• lung-protective ventilation [Time frame: 4 hours]

Secondary outcome measures (4)

• Rate (hours) with set tidal volume < 6cc/kg PBW [Time frame: 72 hours]
• Rate (hours) exposure to >8 cc/kg PBW [Time frame: 72 hours]
• Rate (hours) exposure to >10 cc/kg PBW [Time frame: 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? [Time frame: 72 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Minnesota — Minneapolis

Identifiers

NCT: NCT06895148 · ADHERE-LPV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗