Improving delivery of lung-protective ventilation with EHR ventilator defaults
ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
This project will test whether changing ventilator order defaults in the electronic health record helps adults on mechanical ventilation receive lung-protective ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06895148 on ClinicalTrials.gov |
What this trial studies
This is a cluster-randomized trial across ten hospitals, stratified by hospital size, with randomization occurring at the hospital level. Hospitals in the intervention arm will implement an EHR-based change to ventilator orders designed to encourage default settings aligned with lung-protective ventilation for a nine-month period, after which the intervention will be rolled out to all sites. The design allows comparison of patient outcomes before and after the change within hospitals as well as between hospitals that have and have not yet received the intervention. Eligible patients are adults requiring mechanical ventilation, with several exclusions such as prior ECMO, elective surgical admissions, very short duration of ventilation, or modes that do not use set tidal volumes.
Who should consider this trial
Good fit: Adults aged 18 and over who require mechanical ventilation at participating hospitals and who do not meet exclusion criteria such as prior ECMO or elective surgical admission are the ideal candidates.
Not a fit: Patients unlikely to benefit include those ventilated for less than 12 hours, those on ECMO, patients whose ventilator mode does not require a set tidal volume, elective surgical admissions, patients who opted out of research, and those with recorded height under 4 feet.
Why it matters
Potential benefit: If successful, the EHR-default approach could increase adherence to lung-protective ventilation and reduce ventilator-related lung injury, potentially improving survival and shortening ICU stays.
How similar studies have performed: Previous implementation and quality-improvement efforts using EHR defaults and protocols have improved adherence to lung-protective ventilation, although large cluster-randomized evaluations of this exact EHR-default strategy are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Nick Ingraham, MD, MS
- Email: ingra107@umn.edu
- Phone: (612) 624-0999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.