Implementation of Neuro Lung Protective Ventilation

NCT03243539 | Active Not Recruiting

• 1 other identifier: 1050582
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Brain Injury; Traumatic Brain Injury; Intracerebral Hemorrhage; Stroke; Cerebral Edema; Anoxic Brain Injury

Keywords

lung protective ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

  Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days

• Hospital Discharge Disposition

  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

Study Arms (1)

Lung Protective Ventilation

EXPERIMENTAL

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

Interventions

Lung Protective Ventilation PROCEDURE

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)

Lung Protective Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colin Grissom: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Cerebral Hemorrhage; Stroke; Brain Edema; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Colin K Grissom, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Medical Director Shock Trauma ICU

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 9, 2017
• Study Start: August 31, 2017
• Primary Completion: December 31, 2018
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)