N/A
N=824
Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
ARDS · Critical Illness · Acute Respiratory Distress Syndrome · Acute Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT04663802 ↗Enrolled (actual)
824
Serious AEs
3.6%
Results posted
Oct 2024
Primary outcome: Primary: Fidelity to LPV — 43.3; 19.1; 83.9; 31.0 Percentage of time during first 72 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Default order set (Behavioral); Physician-targeted accountable justification (Behavioral); Respiratory therapist (RT)-targeted accountable justification (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fidelity to LPV |
43.3; 19.1; 83.9; 31.0; 67.8 | — |
| SECONDARY Total Duration of Exposure to Tidal Volume >8 cc/kg PBW |
0.08; 0.51; 0; 0.37; 0.09 | — |
| SECONDARY Total Duration of Exposure to Tidal Volume >10 cc/kg PBW |
0; 0; 0; 0; 0 | — |
| SECONDARY Initial Tidal Volume Administered |
1628; 539; 347; 822; 562; 1348 | — |
| SECONDARY Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) |
126; 26; 37; 34; 43; 2310 | — |
| SECONDARY Hospital Mortality |
977; 294; 268; 417; 437 | — |
| SECONDARY ICU-free Days |
18; 16; 18.5; 19; 18 | — |
| SECONDARY Hospital Free Days |
2; 0; 0.5; 2; 0 | — |
| SECONDARY Ventilator Free Days |
22; 23; 21; 25; 21.5 | — |
| SECONDARY Hospital Discharge Disposition |
188; 63; 63; 108; 100; 844 | — |
| SECONDARY Early Deep Sedation |
33; 33; 33; 33; 33 | — |
| SECONDARY Average Sedation Intensity Within the First 72 Hours |
-2.09; -2.56; -1.8; -2.59; -1.99 | — |
| SECONDARY Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation |
594; 264; 119; 392; 229; 2362 | — |
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 (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.
Eligibility Criteria
Inclusion Criteria
- Aged 18 and over; AND
- Admission to 1 of the 12 participating ICUs; AND
- Undergoing mechanical ventilation
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04663802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.