Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Not Applicable

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: Implementation of Processes

• Registration Number: NCT03984175
• Lead Sponsor: Intermountain Health Care, Inc.

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

Study Timeline

• Study Start: 2018-07-08
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with ARDS at three Intermountain tertiary hospitals	Implementation of Processes	-

Primary Outcome Measures

Name	Time	Method
LTVV Compliance	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 Outcome Measures

Name	Time	Method
Utilization of Ventilation Protocol (continuous)	through study completion - 6 months	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
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	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)
Utilization of Oxygenation Protocol (continuous)	through study completion - 6 months	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
LTVV Compliance >90% (binary)	through study completion - 6 months	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
PEEP FI02 Compliance >70% (binary)	through study completion - 6 months	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)

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States