NCT06895148 ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
| NCT ID | NCT06895148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,125 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,125 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06895148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895148 currently recruiting?
Yes, NCT06895148 is actively recruiting participants. Contact the research team at ingra107@umn.edu for enrollment information.
Where is the NCT06895148 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06895148 clinical trial?
NCT06895148 is sponsored by University of Minnesota. The trial plans to enroll 1,125 participants.