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

ConditionVentilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 and over

Requires mechanical ventilation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • New ventilator

    Device

    The new ventilator order (intervention) was developed using economic behavior theory to decrease the cognitive burden on the ordering provider while enhancing the operability of the order itself. The strategy resulted in a new ventilator order that includes the following changes: 1. Automatic calculation of the PBW based on the most recent height 2. If the height is not available, an order to obtain a height will be generated and the choice of tidal volume will be based on cc/kg PBW 3. Simplify ventilator modes to accurately reflect the standard of care 4. Reduce duplicative information in the monitoring and comments portion of the order 5. Cascade ventilator orders based on mode to enhance visualization.

  • control ventilator

    Device

    Current ventilator order used by control hospitals

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Standard of Care VentilatorActive comparator 1 intervention
Group B: Experimental VentilatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

lung-protective ventilation

The primary outcome is a binary indicator of lung-protective ventilation (set tidal volume of 8 mL/kg predicted body weight or less) at the first documented set tidal volume at least 4 hours after the start of invasive mechanical ventilation.

Time frame
4 hours

Secondary outcomes

1

Rate (hours) with set tidal volume < 6cc/kg PBW

Time frame
72 hours
2

Rate (hours) exposure to >8 cc/kg PBW

Time frame
72 hours
3

Rate (hours) exposure to >10 cc/kg PBW

Time frame
72 hours
4

Time to adhere to ≤ 8 cc/kg per day: Of all patients set to >8 cc/kg per day, how long did it take for the patient to receive ≤ 8 cc/kg per day?

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.