Ventilation
Conditions
Brief summary
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.
Interventions
DEVICENew ventilator
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.
DEVICEcontrol ventilator
Current ventilator order used by control hospitals
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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. The intervention will be tested within the MHFV health system which includes a 10-hospital network admitting over 2,500 mechanically ventilated patients annually.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lung-protective ventilation | 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
| Measure | Time frame |
|---|---|
| Rate (hours) with set tidal volume < 6cc/kg PBW | 72 hours |
| Rate (hours) exposure to >8 cc/kg PBW | 72 hours |
| Rate (hours) exposure to >10 cc/kg PBW | 72 hours |
| 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? | 72 hours |
Countries
United States
Contacts
CONTACTNick Ingraham, MD, MS
Outcome results
None listed