Implementation of Neuro Lung Protective Ventilation (NEUROVENT)

Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Traumatic Brain Injury; Acute Brain Injury; Intracerebral Hemorrhage; Cerebral Edema; Anoxic Brain Injury
• Intervention / Treatment: Procedure: Lung Protective Ventilation

• Study Type: Interventional
• Enrollment (Estimated): 728
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW	Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of time with a target PaCO2 of 35 to 45 mm Hg		Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
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	Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Hospital Discharge Disposition	Routine, skilled nursing facility, home health, other	Day of hospital discharge, an average of 10 days after admission
Hospital, 28-Day, and 90-Day Mortality		Hospital admission through 90 days
Ventilator-free days to day 28		Initiation of mechanical ventilation to day 28
Time to First ICU Activity		Day of admission to day of first ICU activity, an average of 0.2 days
Hospital, ICU Length of Stay		Day of admission to day of discharge, an average of 10 days
Health Care Utilization	Number of procedures/surgeries while in the hospital and number of days of hospitalization	Day of admission to day of discharge, an average of 10 days
Costs of Care		Day of admission to day of discharge, an average of 10 days
Quality of Life - up to 1 year after day of discharge	May include SF-36 or similar measures	Day of admission until up to 1 year after day of discharge

Collaborators and Investigators

• Sponsor: Colin Grissom
• Investigators: Principal Investigator: Colin K Grissom, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: lung protective ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Cerebral Hemorrhage; Brain Edema
• Other Study ID Numbers: 1050582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No