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NCT Number: NCT03243539

Implementation of Neuro Lung Protective Ventilation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Brain Injury Anoxic Brain Injury Brain Diseases Brain Edema Brain Injuries Brain Injuries, Traumatic Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Edema Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Intracerebral Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center

Murray, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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 - up to 1 year after day of discharge

    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

Sponsors and collaborators

Lead sponsor

Colin Grissom

Other

Registry information

Official study title

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

Acronym: NEUROVENT

Important dates

Study start
2017
Primary completion
2018
Study completion
2026
First posted
Aug 9, 2017
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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