CClinicalTrials.gg
Active, not recruitingNCT03243539NEUROVENTUpdated Apr 8, 2026

Implementation of Neuro Lung Protective Ventilation

An interventional study of Lung Protective Ventilation in Acute Brain Injury, Traumatic Brain Injury and Intracerebral Hemorrhage, sponsored by Colin Grissom. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Colin Grissom · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
728
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • lung protective ventilation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
728 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureLung 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)

05

What researchers measure

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)

    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

  3. Hospital Discharge Disposition

    Routine, skilled nursing facility, home health, other

    Time frame: Day of hospital discharge, an average of 10 days after admission

  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

    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

  9. Quality of Life - up to 1 year after day of discharge

    May include SF-36 or similar measures

    Time frame: Day of admission until up to 1 year after day of discharge

  10. Costs of Care

    Time frame: Day of admission to day of discharge, an average of 10 days

06

Study locations

1 site
  • Intermountain Medical Center
    Murray, Utah 84107, United States
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.

08

Registry details

Key details

Study ID
NCT03243539
Lead sponsor
Colin Grissom
Responsible party
Colin Grissom (Co-Medical Director Shock Trauma ICU, Intermountain Health Care, Inc.) — Sponsor-investigator
First posted
Aug 9, 2017
Start date
Aug 31, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Colin K Grissom, MD
principal investigator · Intermountain Health Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion