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.

Study Overview

• Status: Completed
• Conditions: Ventilator-Induced Lung Injury; Acute Brain Injury; Cerebrovascular Circulation
• Intervention / Treatment: Procedure: Lung protective ventilator settings

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9010
      • University Hospital North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Any tracheally intubated or tracheotomized adult patient with ABI with GCS< 9 on controlled ventilation requiring continuous ICP measurement.
• 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 and Xray pathology
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial pressure	intracranial pressure increase with lung protective setting	120 minutes
pressure reactivity index	Diminished pressure reactivity index	120 minutes

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; Hôpital de la Croix-Rousse
• Investigators: Principal Investigator: Shirin K Frisvold, University Hospital of North Norway

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1007/978-3-211-85578-2_30.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Craniocerebral Trauma; Trauma, Nervous System; Thoracic Injuries; Brain Injuries; Wounds and Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: Brain-Vent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No