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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 : April 30, 2019
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Brain Injury Ventilator-Induced Lung Injury Cerebrovascular Circulation Procedure: Lung protective ventilator settings Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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 : June 1, 2019
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




Primary Outcome Measures :
  1. Intracranial pressure [ Time Frame: 120 minutes ]
    intracranial pressure increase with lung protective setting

  2. pressure reactivity index [ Time Frame: 120 minutes ]
    Diminished pressure reactivity index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Any tracheally intubated or tracheotomized adult patient with ABI with GCS< 9 on controlled ventilation requiring continuous ICP measurement.
  • Admission within 24 h after ABI.
  • Proxy informed consent from relatives.

Exclusion Criteria:

  • • ICP > 22 mmHg before treatment of high ICP
  • Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio < 40 kPa
  • History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.
  • Body mass index (BMI) > 35.
  • Known right or biventricular cardiac failure with cardiac index < 2,5 L/min/m2 or ejection fracture < 40 %.
  • Refractory hypovolemia as diagnosed with pulse pressure variation > 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with > 10 % increase in stroke volume measured by VTI echocardiography or PICCO.
  • Medulla lesion that affect the autonomic nervous system.
  • Patients who has undergone decompressive craniectomy.

Information from the National Library of Medicine

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


Contacts
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Contact: Shirin K Frisvold, MD PhD +4777669605 shirin.kordasti@unn.no

Sponsors and Collaborators
University Hospital of North Norway
Cambridge University Hospitals NHS Foundation Trust
Hôpital de la Croix-Rousse
Investigators
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Principal Investigator: Shirin K Frisvold University Hospital of North Norway
Publications:
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Responsible Party: Shirin Kordasti Frisvold, Principal investigator, PhD, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03278769    
Other Study ID Numbers: Brain-Vent
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries