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Clinical Trials/NCT03984175
NCT03984175
Unknown
N/A

Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome

Intermountain Health Care, Inc.1 site in 1 country350 target enrollmentJuly 8, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Intermountain Health Care, Inc.
Enrollment
350
Locations
1
Primary Endpoint
LTVV Compliance
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 8, 2018
End Date
December 23, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

LTVV Compliance

Time Frame: through study completion - 6 months

Defined as: % of time each patient is on a compliant tidal volume for the duration of mechanical ventilation. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for each patient (proportion of mechanically ventilated hours, excluding hours on appropriate CPAP/PS)

Secondary Outcomes

  • Utilization of Ventilation Protocol (continuous)(through study completion - 6 months)
  • Ventilator-Free Days (VFD) to Day 28(through study completion - 6 months)
  • % of Patients who do not survive to day 28(through study completion - 6 months)
  • PEEP FI02 Compliance (continuous variable)(through study completion - 6 months)
  • Utilization of Oxygenation Protocol (continuous)(through study completion - 6 months)
  • LTVV Compliance >90% (binary)(through study completion - 6 months)
  • PEEP FI02 Compliance >70% (binary)(through study completion - 6 months)

Study Sites (1)

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