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Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure (IMPROVENT)

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ClinicalTrials.gov Identifier: NCT03225807
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Colin Grissom, Intermountain Health Care, Inc.

Brief Summary:

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes.

The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes.

The objectives of this study are to:

  • Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation
  • Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS)
  • Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

Condition or disease
Acute Respiratory Distress Syndrome ARDS Respiratory Distress Syndrome, Acute Respiratory Insufficiency Respiratory Distress Syndrome Shock Lung Severe Acute Respiratory Syndrome

Detailed Description:

Study Design:

This is an observational quality improvement study comparing outcomes before, and after, implementation of a proven lung protective ventilation protocol in an electronic medical record system, iCentra, that will be implemented in phases across Intermountain Healthcare hospitals. A phased implementation with a two-month washout period will be used to evaluate the primary outcome of interest, ventilator free days (VFDs) to 28 days. Secondary outcomes will include: use of the protocol by clinicians, compliance with protocol instructions, hospital discharge disposition, hospital, 30-day, and 90-day mortality, time to first ICU activity, hospital length of stay, ICU length of stay, heath care utilization, quality of life, and costs of care. As the iCentra electronic medical record is implemented at Intermountain Healthcare hospitals, clinicians will have the opportunity to use the computerized lung protective ventilation protocol, or to order mechanical ventilation settings independently. This is an observational study designed to measure how often the computerized lung protective ventilation protocol will be ordered, compliance with the instructions of the protocol, and clinical outcomes among patients who are managed with the protocol. Physicians may choose to use the protocol on intubated patients requiring mechanical ventilation or they may choose to order other specific mechanical ventilator settings.

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
Study Start Date : March 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020





Primary Outcome Measures :
  1. Ventilator free days to day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days ]
  2. 90 day mortality [ Time Frame: 90 days ]
  3. Hospital discharge disposition [ Time Frame: 30 days ]
  4. Hospital mortality [ Time Frame: 1 week ]
  5. Time to first ICU activity [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient Selection Those to be enrolled must have respiratory failure requiring intubation and initiation of mechanical ventilation. Patients will be divided into two different groups: those patients who are managed with the computerized lung protective ventilation protocol as ordered by the attending physician and those patients managed with physician specified mechanical ventilation settings.
Criteria

Inclusion Criteria

  1. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
  2. Age ≥ 18 years

Exclusion Criteria

  1. Transition to comfort care in the emergency department or on the same day of admission to the ICU
  2. Death on the same day of admission to the emergency department or ICU

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): NCT03225807


Contacts
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Contact: Colin Grissom, MD 801-507-6554 Colin.Grissom@imail.org
Contact: Anne Haroldsen (801) 507-4607 Anne.Haroldsen@imail.org

Locations
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United States, Utah
Colin Grissom Recruiting
Murray, Utah, United States, 84121
Contact: Colin Grissom, MD    801-507-6554    colin.grissom@imail.org   
Contact: Valerie Aston, MBA    801-    Valerie.Aston@imail.org   
Sub-Investigator: Michael Lanspa, MD         
Sub-Investigator: Samuel M. Brown, MD         
Sub-Investigator: Ithan Peltan, MD         
Sub-Investigator: Russ Miller, MD         
Sub-Investigator: Dave Collingridge, PhD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Colin Grissom, MD Intermountain Health Care, Inc.
  Study Documents (Full-Text)

Documents provided by Colin Grissom, Intermountain Health Care, Inc.:
Study Protocol  [PDF] September 27, 2016

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Responsible Party: Colin Grissom, Principal Investigator, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03225807    
Other Study ID Numbers: 1050159
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared.
Keywords provided by Colin Grissom, Intermountain Health Care, Inc.:
Intubated
Intubation
Ventilator
Ventilator-free days
Ventilator free days
Mechanical Ventilation
Meta-Analysis
Tidal Volume
Tidal Volumes
inflammation
cytokines
Pulmonary Infiltrate
Pulmonary Infiltrates
Low Tidal Volumes
Protective Ventilation
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Pulmonary Valve Insufficiency
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections