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Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation of Processes
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Lung Protective Mechanical Ventilation, Clinical Decision Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Intermountain Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with ARDS at three Intermountain tertiary hospitals

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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
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
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)
Ventilator-Free Days (VFD) to Day 28
% of Patients who do not survive to day 28

Full Information

First Posted
June 3, 2019
Last Updated
August 1, 2022
Sponsor
Intermountain Health Care, Inc.
Collaborators
National Institutes of Health (NIH), McKay-Dee Hospital, Utah Valley Hospital, Dixie Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03984175
Brief Title
Clinical Decision Support for Mechanical Ventilation of Patients With ARDS
Official Title
Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2018 (Actual)
Primary Completion Date
December 23, 2022 (Anticipated)
Study Completion Date
December 23, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
National Institutes of Health (NIH), McKay-Dee Hospital, Utah Valley Hospital, Dixie Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, Lung Protective Mechanical Ventilation, Clinical Decision Support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and After Comparison
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with ARDS at three Intermountain tertiary hospitals
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Implementation of Processes
Intervention Description
Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol
Primary Outcome Measure Information:
Title
LTVV Compliance
Description
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)
Time Frame
through study completion - 6 months
Secondary Outcome Measure Information:
Title
PEEP FI02 Compliance (continuous variable)
Description
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)
Time Frame
through study completion - 6 months
Title
Utilization of Ventilation Protocol (continuous)
Description
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
Time Frame
through study completion - 6 months
Title
Utilization of Oxygenation Protocol (continuous)
Description
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
Time Frame
through study completion - 6 months
Title
LTVV Compliance >90% (binary)
Description
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
Time Frame
through study completion - 6 months
Title
PEEP FI02 Compliance >70% (binary)
Description
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)
Time Frame
through study completion - 6 months
Title
Ventilator-Free Days (VFD) to Day 28
Time Frame
through study completion - 6 months
Title
% of Patients who do not survive to day 28
Time Frame
through study completion - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin K Grissom, MD
Phone
801-507-6554
Email
colin.grissom@imail.org
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Aston
Phone
801-507-4606
Email
valerie.aston@imail.org
First Name & Middle Initial & Last Name & Degree
Carlos Barbagelata
Phone
801-507-4607
Email
carlos.barbagelata@imail.org
First Name & Middle Initial & Last Name & Degree
Joseph Bledsoe, MD
First Name & Middle Initial & Last Name & Degree
Samuel Brown, MD
First Name & Middle Initial & Last Name & Degree
Lori Carpenter
First Name & Middle Initial & Last Name & Degree
Andrew Knighton, PhD
First Name & Middle Initial & Last Name & Degree
Michael Lanspa, MD
First Name & Middle Initial & Last Name & Degree
Scott Narus, MD
First Name & Middle Initial & Last Name & Degree
Ithan Peltan, MD
First Name & Middle Initial & Last Name & Degree
Rajendu Srivastava, MD
First Name & Middle Initial & Last Name & Degree
Scott Stevens, MD
First Name & Middle Initial & Last Name & Degree
Lindsay Leither, DO

12. IPD Sharing Statement

Citations:
PubMed Identifier
36350983
Citation
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. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC.
Results Reference
derived

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Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

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