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Recruiting

NCT Number: NCT06895148

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

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.

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Key information

Conditions

Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Nick Ingraham, MD, MS

CONTACT

[email protected]

612-624-0999

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • Automatic calculation of the PBW based on the most recent height
  • 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
  • Simplify ventilator modes to accurately reflect the standard of care
  • Reduce duplicative information in the monitoring and comments portion of the order
  • Cascade ventilator orders based on mode to enhance visualization.

control ventilator

Device

Current ventilator order used by control hospitals

Primary outcomes

  1. lung-protective ventilation

    Time frame: 4 hours

    The primary outcome is a binary indicator of lung-protective ventilation (ventilator set at ≤ 8 cc/kg) at the first documented set tidal volume after 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nick Ingraham, MD, MS

CONTACT

[email protected]

(612) 624-0999

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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