Acute Brain InjuryNEUROVENTNCT03243539
Implementation of Neuro Lung Protective Ventilation
A study testing Lung Protective Ventilation in people with Acute Brain Injury and Traumatic Brain Injury, run by Colin Grissom at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage
- What is being tested?
- Lung Protective Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage, Stroke, Cerebral Edema, Anoxic Brain Injury
- Being tested
- Lung Protective Ventilation
- Keywords
- lung protective ventilation
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Cerebral Hemorrhage, Stroke, Brain Edema, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Protective VentilationProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lung Protective Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW
Measured: 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
Measured: 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
Measured: 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
Measured: Day of hospital discharge, an average of 10 days after admission
Hospital, 28-Day, and 90-Day Mortality
Measured: Hospital admission through 90 days
Ventilator-free days to day 28
Measured: Initiation of mechanical ventilation to day 28
Time to First ICU Activity
Measured: Day of admission to day of first ICU activity, an average of 0.2 days
Hospital, ICU Length of Stay
Measured: 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
Measured: 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
Measured: Day of admission until up to 1 year after day of discharge
Costs of Care
Measured: Day of admission to day of discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start31 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colin Grissom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colin Grissom, Intermountain Health Care, Inc.
- Investigators
- Colin K Grissom, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243539
- Sponsor's protocol ID
- 1050582
- Acronym
- NEUROVENT
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2017
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT03243539
- Acronym / sponsor ID
- NEUROVENT / 1050582
- Conditions
- Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage, Stroke, Cerebral Edema, Anoxic Brain Injury
- Keywords
- lung protective ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Colin GrissomUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Protective Ventilation | Experimental | Procedure: Lung Protective VentilationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Protective VentilationNeuro 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) | Procedure or surgery | Lung Protective Ventilation |
Primary outcome
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
10 secondary outcomes
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
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
Hospital Discharge Disposition
Time frame: Day of hospital discharge, an average of 10 days after admission
Hospital, 28-Day, and 90-Day Mortality
Time frame: Hospital admission through 90 days
Ventilator-free days to day 28
Time frame: Initiation of mechanical ventilation to day 28
Time to First ICU Activity
Time frame: Day of admission to day of first ICU activity, an average of 0.2 days
Hospital, ICU Length of Stay
Time frame: Day of admission to day of discharge, an average of 10 days
Health Care Utilization
Time frame: Day of admission to day of discharge, an average of 10 days
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
Costs of Care
Time frame: Day of admission to day of discharge, an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin K Grissom, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Protective Ventilation in people with Acute Brain Injury and Traumatic Brain Injury, run by Colin Grissom at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.