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Implementation of Neuro Lung Protective Ventilation (NEUROVENT)

Primary Purpose

Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung Protective Ventilation
Sponsored by
Colin Grissom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Brain Injury focused on measuring lung protective ventilation

Eligibility Criteria

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

Inclusion Criteria:

  1. Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.
  2. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
  3. 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

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung Protective Ventilation

Arm Description

Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.

Outcomes

Primary Outcome Measures

Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW

Secondary Outcome Measures

Proportion of time with a target PaCO2 of 35 to 45 mm Hg
Average number of protocol deviations for all subjects (protocol compliance)
Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject
Hospital Discharge Disposition
Routine, skilled nursing facility, home health, other
Hospital, 28-Day, and 90-Day Mortality
Ventilator-free days to day 28
Time to First ICU Activity
Hospital, ICU Length of Stay
Health Care Utilization
Number of procedures/surgeries while in the hospital and number of days of hospitalization
Quality of Life
May include SF-36 or similar measures
Costs of Care

Full Information

First Posted
July 14, 2017
Last Updated
February 23, 2021
Sponsor
Colin Grissom
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1. Study Identification

Unique Protocol Identification Number
NCT03243539
Brief Title
Implementation of Neuro Lung Protective Ventilation
Acronym
NEUROVENT
Official Title
Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Colin Grissom

4. Oversight

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

5. Study Description

Brief Summary
Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required. This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage, Stroke, Cerebral Edema, Anoxic Brain Injury
Keywords
lung protective ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
728 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lung Protective Ventilation
Arm Type
Experimental
Arm Description
Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.
Intervention Type
Procedure
Intervention Name(s)
Lung Protective Ventilation
Intervention Description
Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)
Primary Outcome Measure Information:
Title
Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW
Time Frame
Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Secondary Outcome Measure Information:
Title
Proportion of time with a target PaCO2 of 35 to 45 mm Hg
Time Frame
Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Title
Average number of protocol deviations for all subjects (protocol compliance)
Description
Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject
Time Frame
Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Title
Hospital Discharge Disposition
Description
Routine, skilled nursing facility, home health, other
Time Frame
Day of hospital discharge, an average of 10 days after admission
Title
Hospital, 28-Day, and 90-Day Mortality
Time Frame
Hospital admission through 90 days
Title
Ventilator-free days to day 28
Time Frame
Initiation of mechanical ventilation to day 28
Title
Time to First ICU Activity
Time Frame
Day of admission to day of first ICU activity, an average of 0.2 days
Title
Hospital, ICU Length of Stay
Time Frame
Day of admission to day of discharge, an average of 10 days
Title
Health Care Utilization
Description
Number of procedures/surgeries while in the hospital and number of days of hospitalization
Time Frame
Day of admission to day of discharge, an average of 10 days
Title
Quality of Life
Description
May include SF-36 or similar measures
Time Frame
Day of admission until up to 1 year after day of discharge
Title
Costs of Care
Time Frame
Day of admission to day of discharge, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital Age ≥ 18 years Exclusion Criteria: Transition to comfort care in the emergency department or on the same day of admission to the ICU Death on the same day of admission to the emergency department or ICU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin K Grissom, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.

Learn more about this trial

Implementation of Neuro Lung Protective Ventilation

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