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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment increased: 1125 → 1500 participants
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Minor Primary and study completion dates: Jul 16, 2026 to Dec 31, 2026v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2025 to Jul 1, 2025
    v3
  4. Notable Start date: Apr 16, 2025 to Jun 1, 2025
    • Primary endpoint revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06895148
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Ventilation
Related terms Respiratory Aspiration
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov