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Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

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ClinicalTrials.gov Identifier: NCT03984175
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
McKay-Dee Hospital
Utah Valley Hospital
Dixie Regional Hospital
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Procedure: Implementation of Processes Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Before and After Comparison
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : July 8, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PEEP FI02 Compliance (continuous variable) [ Time Frame: 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)


  2. Utilization of Ventilation Protocol (continuous) [ Time Frame: 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


  3. Utilization of Oxygenation Protocol (continuous) [ Time Frame: 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


  4. LTVV Compliance >90% (binary) [ Time Frame: 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


  5. PEEP FI02 Compliance >70% (binary) [ Time Frame: 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)


  6. Ventilator-Free Days (VFD) to Day 28 [ Time Frame: through study completion - 6 months ]
  7. % of Patients who do not survive to day 28 [ Time Frame: through study completion - 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984175


Contacts
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Contact: Colin K Grissom, MD 801-507-6554 colin.grissom@imail.org

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Valerie Aston    801-507-4606    valerie.aston@imail.org   
Contact: Carlos Barbagelata    801-507-4607    carlos.barbagelata@imail.org   
Sub-Investigator: Joseph Bledsoe, MD         
Sub-Investigator: Samuel Brown, MD         
Sub-Investigator: Lori Carpenter         
Sub-Investigator: Andrew Knighton, PhD         
Sub-Investigator: Michael Lanspa, MD         
Sub-Investigator: Scott Narus, MD         
Sub-Investigator: Ithan Peltan, MD         
Sub-Investigator: Rajendu Srivastava, MD         
Sub-Investigator: Scott Stevens, MD         
Sub-Investigator: Lindsay Leither, DO         
Sponsors and Collaborators
Intermountain Health Care, Inc.
National Institutes of Health (NIH)
McKay-Dee Hospital
Utah Valley Hospital
Dixie Regional Hospital

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03984175     History of Changes
Other Study ID Numbers: 1050867
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Intermountain Health Care, Inc.:
ARDS
Lung Protective Mechanical Ventilation
Clinical Decision Support

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury