Ventilator Settings on Patients With Acute Brain Injury

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Principal Investigator:	Shirin K Frisvold	University Hospital of North Norway

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51.

Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4. Review.

Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG—Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22. Review.

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
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