Ventilator Settings on Patients With Acute Brain Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03278769|
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
|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|
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278769
|Contact: Shirin K Frisvold, MD PhDfirstname.lastname@example.org|
|Principal Investigator:||Shirin K Frisvold||University Hospital of North Norway|