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Trial record 54 of 667 for:    CARBON DIOXIDE AND arterial

Implementation of Neuro Lung Protective Ventilation (NEUROVENT)

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ClinicalTrials.gov Identifier: NCT03243539
Recruitment Status : Active, not recruiting
First Posted : August 9, 2017
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Colin Grissom, Intermountain Health Care, Inc.

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.


Condition or disease Intervention/treatment Phase
Acute Brain Injury Traumatic Brain Injury Intracerebral Hemorrhage Stroke Cerebral Edema Anoxic Brain Injury Procedure: Lung Protective Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 728 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury
Actual Study Start Date : August 31, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Lung Protective Ventilation
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.
Procedure: Lung Protective Ventilation
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 Measures :
  1. 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 Measures :
  1. 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 ]
  2. Average number of protocol deviations for all subjects (protocol compliance) [ Time Frame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days ]
    Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject

  3. Hospital Discharge Disposition [ Time Frame: Day of hospital discharge, an average of 10 days after admission ]
    Routine, skilled nursing facility, home health, other

  4. Hospital, 28-Day, and 90-Day Mortality [ Time Frame: Hospital admission through 90 days ]
  5. Ventilator-free days to day 28 [ Time Frame: Initiation of mechanical ventilation to day 28 ]
  6. Time to First ICU Activity [ Time Frame: Day of admission to day of first ICU activity, an average of 0.2 days ]
  7. Hospital, ICU Length of Stay [ Time Frame: Day of admission to day of discharge, an average of 10 days ]
  8. Health Care Utilization [ Time Frame: Day of admission to day of discharge, an average of 10 days ]
    Number of procedures/surgeries while in the hospital and number of days of hospitalization

  9. Quality of Life [ Time Frame: Day of admission until up to 1 year after day of discharge ]
    May include SF-36 or similar measures

  10. Costs of Care [ Time Frame: Day of admission to day of discharge, an average of 10 days ]


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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. 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

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): NCT03243539


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Sponsors and Collaborators
Colin Grissom
Investigators
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Principal Investigator: Colin K Grissom, MD Intermountain Health Care, Inc.
  Study Documents (Full-Text)

Documents provided by Colin Grissom, Intermountain Health Care, Inc.:

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Responsible Party: Colin Grissom, Co-Medical Director Shock Trauma ICU, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03243539     History of Changes
Other Study ID Numbers: 1050582
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.

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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 Colin Grissom, Intermountain Health Care, Inc.:
lung protective ventilation
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cerebral Hemorrhage
Brain Edema
Hemorrhage
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases