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Ventilator Settings on Patients With Acute Brain Injury

Primary Purpose

Acute Brain Injury, Ventilator-Induced Lung Injury, Cerebrovascular Circulation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lung protective ventilator settings
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital North Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ventilator setting

Arm Description

Positive end-expiratory pressure , Tidal volume

Outcomes

Primary Outcome Measures

Intracranial pressure
intracranial pressure increase with lung protective setting
pressure reactivity index
Diminished pressure reactivity index

Secondary Outcome Measures

Full Information

First Posted
August 29, 2017
Last Updated
May 16, 2022
Sponsor
University Hospital of North Norway
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse
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1. Study Identification

Unique Protocol Identification Number
NCT03278769
Brief Title
Ventilator Settings on Patients With Acute Brain Injury
Official Title
Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of North Norway
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury, Ventilator-Induced Lung Injury, Cerebrovascular Circulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventilator setting
Arm Type
Experimental
Arm Description
Positive end-expiratory pressure , Tidal volume
Intervention Type
Procedure
Intervention Name(s)
Lung protective ventilator settings
Intervention Description
Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
Primary Outcome Measure Information:
Title
Intracranial pressure
Description
intracranial pressure increase with lung protective setting
Time Frame
120 minutes
Title
pressure reactivity index
Description
Diminished pressure reactivity index
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirin K Frisvold
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital North Norway
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9010
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19388307
Citation
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.
Results Reference
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PubMed Identifier
26855895
Citation
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.
Results Reference
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PubMed Identifier
27334266
Citation
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.
Results Reference
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Ventilator Settings on Patients With Acute Brain Injury

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