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NCT06895148 | NOT YET RECRUITING | Ventilation

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

The 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.

Condition or disease

Ventilation

Intervention/treatment

New ventilator

control ventilator

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1125 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
Actual Study Start Date : 2025-04-16
Estimated Primary Completion Date : 2026-07-16
Estimated Study Completion Date : 2026-07-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation

Location Details

NCT06895148

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Locations

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