Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Implementation of Processes

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 Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colin K Grissom, MD; Phone Number: 801-507-6554; Email: colin.grissom@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center
      • Contact: Valerie Aston; Phone Number: 801-507-4606; Email: valerie.aston@imail.org
      • Sub-Investigator: Ithan Peltan, MD
      • Sub-Investigator: Samuel Brown, MD
      • Sub-Investigator: Lindsay Leither, DO
      • Sub-Investigator: Michael Lanspa, MD
      • Sub-Investigator: Joseph Bledsoe, MD
      • Sub-Investigator: Scott Stevens, MD
      • Contact: Carlos Barbagelata; Phone Number: 801-507-4607; Email: carlos.barbagelata@imail.org
      • Sub-Investigator: Lori Carpenter
      • Sub-Investigator: Andrew Knighton, PhD
      • Sub-Investigator: Scott Narus, MD
      • Sub-Investigator: Rajendu Srivastava, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: National Institutes of Health (NIH); McKay-Dee Hospital; Utah Valley Hospital; Dixie Regional Hospital

Publications and helpful links

General Publications

• 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. 2022 Nov 9. doi: 10.1513/AnnalsATS.202207-626OC. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2018
• Primary Completion (Anticipated): December 23, 2022
• Study Completion (Anticipated): December 23, 2022

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Clinical Decision Support; ARDS; Lung Protective Mechanical Ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 1050867

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No