Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Implementation of Processes


Participation Criteria
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Eligibility Criteria
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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 Prisoner 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Before and After Comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with ARDS at three Intermountain tertiary hospitals<br> | Procedure: Implementation of Processes<br>* Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LTVV Compliance | 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) | through study completion - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEEP FI02 Compliance (continuous variable) | Defined as: % of time each patient is on a compliant FI02 and PEEP combination. Measured as: using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations, (proportion of ventilated hours, excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) | through study completion - 6 months | 
| Utilization of Ventilation Protocol (continuous) | Defined as: % of time each patient is managed with the computerized ventilation protocol. Measured as: Running the computerized ventilation protocol whenever a ventilator check is performed and an arterial blood gas was done within the previous hour, excluding hours on appropriate CPAP/PS | through study completion - 6 months | 
| Utilization of Oxygenation Protocol (continuous) | Defined as: % of time each patient is managed with the computerized oxygenation protocol. Measured as: Running the computerized oxygenation protocol at least every four hours when a ventilator check was performed, excluding hours on appropriate CPAP/PS | through study completion - 6 months | 
| LTVV Compliance >90% (binary) | Defined as: meeting, or not meeting, the target LTVV compliance of >90% for each patient. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for 90% or more of mechanically ventilated hours, excluding hours on appropriate CPAP/PS | through study completion - 6 months | 
| PEEP FI02 Compliance >70% (binary) | Defined as: meeting, or not meeting, the target PEEP FI02 compliance of >70% for each patient. Measured as: Using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations for at least 70% of mechanically ventilated hours (excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, Lung Protective Mechanical Ventilation, Clinical Decision Support