New Ventilator for Lung Health

Overseen By Nick Ingraham, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Opted out, ECMO, Elective surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

The ADHERE-LPV trial is for adults aged 18 and over who require mechanical ventilation. It's designed to test if a new strategy in hospitals can improve the use of lung-protective ventilation (LPV) techniques.

Inclusion Criteria

Requires mechanical ventilation

I am 18 years old or older.

Exclusion Criteria

The mode ordered does not require a set tidal volume

Requires ECMO prior to ICU admission

Data during the use of ECMO

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of an EHR-based strategy to enhance adherence to lung-protective ventilation for a 9-month period

9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADHERE-LPV

Trial Overview This study compares patient outcomes using two different ventilators: a new one with an EHR-based strategy promoting LPV, versus a control ventilator without this feature. Hospitals are randomly chosen to use either the new or control ventilator.

How Is the Trial Designed?

Group I: Experimental Ventilator Experimental Treatment 1 Intervention

Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order

Group II: Standard of Care Ventilator Active Control 1 Intervention

Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to the current ventilator order that is used across the health system.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+