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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
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
Hôpital de la Croix-Rousse
Information provided by (Responsible Party):
Shirin Kordasti Frisvold, University Hospital of North Norway

August 29, 2017
September 12, 2017
September 12, 2017
February 1, 2018
February 1, 2020   (Final data collection date for primary outcome measure)
  • Intracranial pressure [ Time Frame: 120 minutes ]
    intracranial pressure increase with lung protective setting
  • pressure reactivity index [ Time Frame: 120 minutes ]
    Diminished pressure reactivity index
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Ventilator Settings on Patients With Acute Brain Injury
Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients
The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.

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.

  1. increase intracranial pressure
  2. 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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Acute Brain Injury
  • Ventilator-Induced Lung Injury
  • Cerebrovascular Circulation
Procedure: Lung protective ventilator settings
Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
Experimental: Ventilator setting
Positive end-expiratory pressure , Tidal volume
Intervention: Procedure: Lung protective ventilator settings

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Same as current
February 1, 2022
February 1, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Shirin K Frisvold, MD PhD +4777669605 shirin.kordasti@unn.no
Not Provided
 
 
NCT03278769
Brain-Vent
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Shirin Kordasti Frisvold, University Hospital of North Norway
University Hospital of North Norway
  • Cambridge University Hospitals NHS Foundation Trust
  • Hôpital de la Croix-Rousse
Principal Investigator: Shirin K Frisvold University Hospital of North Norway
University Hospital of North Norway
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP