Ventilator Settings on Patients With Acute Brain Injury
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ClinicalTrials.gov Identifier: NCT03278769 |
Recruitment Status
:
Not yet recruiting
First Posted
: September 12, 2017
Last Update Posted
: September 12, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Brain Injury Ventilator-Induced Lung Injury Cerebrovascular Circulation | Procedure: Lung protective ventilator settings | Not Applicable |
The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.
The primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.
- increase intracranial pressure
- diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.
The secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients |
Estimated Study Start Date : | February 1, 2018 |
Estimated Primary Completion Date : | February 1, 2020 |
Estimated Study Completion Date : | February 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Ventilator setting
Positive end-expiratory pressure , Tidal volume
|
Procedure: Lung protective ventilator settings
Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
|
- Intracranial pressure [ Time Frame: 120 minutes ]intracranial pressure increase with lung protective setting
- pressure reactivity index [ Time Frame: 120 minutes ]Diminished pressure reactivity index

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any tracheally intubated or tracheotomized adult patient with stroke or traumatic brain injury on controlled ventilation requiring continuous intracranial pressure measurement.
- Admission within 24 hours after insult.
- Proxy informed consent from relatives.
Exclusion Criteria:
- Intracranial pressure > 20 mmHg before treatment
- Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction ratio < 40 kiloPascal
- Daily smoker.
- Any chronic respiratory failure diagnosis.
- Abdominal hypertension.
- Body mass index > 30.
- Known right or biventricular cardiac failure with cardiac index < 2,5 L/min/m2 or ejection fracture < 45 %.
- Refractory hypovolemia as diagnosed with pulse pressure variation > 10 % with tidal volume 8 milliliters/predicted bodyweight (intubated) or passive leg rise test with > 10 % increase in stroke volume.
- Medulla lesion that affect the autonomic nervous system
- Patients who has undergone decompressive craniectomy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278769
Contact: Shirin K Frisvold, MD PhD | +4777669605 | shirin.kordasti@unn.no |
Principal Investigator: | Shirin K Frisvold | University Hospital of North Norway |
Publications:
Responsible Party: | Shirin Kordasti Frisvold, Principal investigator, PhD, University Hospital of North Norway |
ClinicalTrials.gov Identifier: | NCT03278769 History of Changes |
Other Study ID Numbers: |
Brain-Vent |
First Posted: | September 12, 2017 Key Record Dates |
Last Update Posted: | September 12, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Wounds and Injuries Brain Injuries Lung Injury Ventilator-Induced Lung Injury Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Lung Diseases Respiratory Tract Diseases Thoracic Injuries |