Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Intermountain Health Care, Inc.

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome

Treatments: Procedure: Implementation of Processes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03984175

1050867

Details and patient eligibility

About

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).

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

Patients with ARDS at three Intermountain tertiary hospitals

Experimental group

Treatment:

Procedure: Implementation of Processes