Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study

Completed · Not applicable

Conditions studied: ARDS, Critical Illness, Acute Respiratory Distress Syndrome, Acute Respiratory Failure

In brief

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 (LPV) utilization among all mechanically ventilated (MV), adult patients. The study will compare the standard approach to managing MV across 12 study Intensive Care Units (ICUs) within University of Pennsylvania Health System (UPHS) versus interventions prompting physicians and respiratory therapists (RTs) to employ LPV settings promote LPV utilization among all MV patients.

Key facts

Study ID

NCT04663802

Run by

University of Pennsylvania

People needed

7342

Starts

2021-02-22

Expected to finish

2023-12-15

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 and over; AND
• Admission to 1 of the 12 participating ICUs; AND
• Undergoing mechanical ventilation

You may not qualify if…

• 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.

Where it is running

• Princeton Medical Center — Plainsboro, New Jersey, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Chester County Hospital — West Chester, Pennsylvania, United States

Full record on ClinicalTrials.gov

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