Clinical trial NCT03984175: Clinical Decision Support for Mechanical Ventilation of Patients With ARDS
Official title: Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Lung Protective Mechanical Ventilation
Clinical Decision Support
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: McKay-Dee Hospital
name: Utah Valley Hospital
name: Dixie Regional Hospital
First posted: 2019-06-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and After Comparison
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).

Detailed description: A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.

Abbreviations for Mechanical Ventilation:

PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters

Eligibility criteria: Inclusion Criteria:

1. Invasive mechanical ventilation
2. PF ratio \<255
3. Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
4. Presence of ≥1 risk factor for ARDS as determined by review of the HER

Exclusion Criteria:

1. Age \<18 years
2. Pulmonary capillary wedge pressure \>18 mm Hg if a right heart catheter is present
3. Prisoner
4. Known to be pregnant
5. Death \<24 hours from initial intubation
6. Placed comfort care \<24 hours from initial intubation
7. Mechanically ventilated for \>7 days prior to meeting ARDS criteria

Primary outcomes:
measure: LTVV Compliance
timeFrame: through study completion - 6 months
Secondary outcomes:
measure: PEEP FI02 Compliance (continuous variable)
timeFrame: through study completion - 6 months
measure: Utilization of Ventilation Protocol (continuous)
timeFrame: through study completion - 6 months
measure: Utilization of Oxygenation Protocol (continuous)
timeFrame: through study completion - 6 months
measure: LTVV Compliance >90% (binary)
timeFrame: through study completion - 6 months
measure: PEEP FI02 Compliance >70% (binary)
timeFrame: through study completion - 6 months
measure: Ventilator-Free Days (VFD) to Day 28
timeFrame: through study completion - 6 months
measure: % of Patients who do not survive to day 28
timeFrame: through study completion - 6 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References:
citation: Peltan ID, Knighton AJ, Barney BJ, Wolfe D, Jacobs JR, Klippel C, Allen L, Lanspa MJ, Leither LM, Brown SM, Srivastava R, Grissom CK. Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial. Ann Am Thorac Soc. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC.