Status:
COMPLETED
Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
ARDS
Critical Illness
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study is a large pragmatic stepped-wedge trial of electronic health record (EHR)-based implementation strategies informed by behavioral economic principles to increase lung-protective ventilation...
Detailed Description
The study is a 5-arm, stepped-wedge cluster randomized trial of electronic health record (EHR)-based implementation strategies set in 12 community and academic intensive care units (ICUs) in 5 hospita...
Eligibility Criteria
Inclusion
- Aged 18 and over; AND
- Admission to 1 of the 12 participating ICUs; AND
- Undergoing mechanical ventilation
Exclusion
- The episode of MV lasts less than 12 hours, because we believe that the evidence-based practice may not apply to these patients nor alter their outcomes.
- The patient is on minimal settings for the entirety of MV, defined as a spontaneous mode (e.g., pressure support ventilation) with pressure support \<10 Centimeters of Water Column (cmH2O), AND positive end-expiratory pressure (PEEP) \<8 cmH20, AND fraction of inspired oxygen (FiO2) \<50%, because the clinical significance of spontaneous tidal volumes is unknown and low tidal volumes may not be beneficial or desirable.
- Goals of care are documented as comfort measures only (as identified through their "code status" field in the EHR) during the first 72 hours during episode of MV, because mechanical ventilation is managed differently during care focused exclusively on comfort and low tidal volume ventilation may not be appropriate, nor would it likely influence clinical outcomes.
- There is no height documented in the EHR at the time of initiation of MV, because we will be unable to estimate ideal body weight, a necessary parameter to calculate the primary outcome, and because they will not receive the interventions.
- The height documented is less than 4 feet, because the formula for ideal body weight does not hold true below this height.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
7342 Patients enrolled
Trial Details
Trial ID
NCT04663802
Start Date
February 22 2021
End Date
December 15 2023
Last Update
October 8 2024
Active Locations (5)
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1
Princeton Medical Center
Plainsboro, New Jersey, United States, 08536
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
4
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107