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Hyperventilation in Patients With Traumatic Brain Injury

Primary Purpose

Head Injury Trauma, Hyperventilation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hyperventilation test
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injury Trauma focused on measuring intracranial pressure, cerebral metabolism, cerebral oxygenation

Eligibility Criteria

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

Inclusion Criteria:

  • nonpenetrating traumatic brain injury
  • Glasgow coma scale <9 at presentation
  • Intracranial pressure monitoring
  • brain tissue oxygen tension monitoring and/or microdialysis monitoring
  • invasive mechanical ventilation with FIO2 <60% and PEEP <15 mbar

Exclusion Criteria:

  • decompressive craniectomy
  • pregnancy
  • pre-existing neurological disease
  • previous traumatic brain injury
  • acute cardiovascular disease
  • severe respiratory failure
  • acute on chronic liver disease
  • sepsis
  • failure to obtain satisfactory bilateral TCCD signals
  • persisting hypovolemia or hemodynamic instability

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with severe TBI

Arm Description

Patients with severe TBI enrolled in the study undergo an hyperventilation test, in which the alveolar ventilation is increased by a stepwise increase in tidal volumes and respiratory rate until a reduction of etCO2 of 0.7 kPa is achieved.

Outcomes

Primary Outcome Measures

intracranial pressure
Change of intracranial pressure during moderate hyperventilation

Secondary Outcome Measures

cerebral flow velocity in the middle cerebral artery
Change of cerebral flow velocity during moderate hyperventilation
brain tissue oxygenation (PbrO2)
no changes
cerebral Lactate/ Pyruvate ratio
no changes

Full Information

First Posted
January 22, 2019
Last Updated
January 29, 2019
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03822026
Brief Title
Hyperventilation in Patients With Traumatic Brain Injury
Official Title
Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 20, 2014 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

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
Elevated intracranial pressure is a dangerous and potentially fatal complication after traumatic brain injury. Hyperventilation is a medical intervention to reduce elevated intracranial pressure by inducing cerebral vasoconstriction, which might be associated to cerebral ischemia and hypoxia. The main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the intracranial pressure without inducing cerebral ischemia.
Detailed Description
In patients with severe traumatic brain injury (TBI), and with intracranial pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes hyperventilation-tests are performed in the acute phase after trauma. Data are collected and TCCD measurements are performed at baseline, at the beginning of moderate hyperventilation, after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline. The present study aims to quantify potential adverse effects of moderate short-term hyperventilation during the acute phase of the severe TBI on cerebral hemodynamics, oxygenation, and metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury Trauma, Hyperventilation
Keywords
intracranial pressure, cerebral metabolism, cerebral oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with severe TBI
Arm Type
Other
Arm Description
Patients with severe TBI enrolled in the study undergo an hyperventilation test, in which the alveolar ventilation is increased by a stepwise increase in tidal volumes and respiratory rate until a reduction of etCO2 of 0.7 kPa is achieved.
Intervention Type
Other
Intervention Name(s)
Hyperventilation test
Intervention Description
Increase of the alveolar ventilation by a stepwise increase in tidal volumes and respiratory rate until a reduction of end-tidal CO2 of 0.7 kPa is achieved
Primary Outcome Measure Information:
Title
intracranial pressure
Description
Change of intracranial pressure during moderate hyperventilation
Time Frame
10, 20, 50, 60 minutes after begin of the hyperventilation test
Secondary Outcome Measure Information:
Title
cerebral flow velocity in the middle cerebral artery
Description
Change of cerebral flow velocity during moderate hyperventilation
Time Frame
20, 50, 60 minutes after begin of the hyperventilation test
Title
brain tissue oxygenation (PbrO2)
Description
no changes
Time Frame
10, 20, 50, 60 minutes after begin of the hyperventilation test
Title
cerebral Lactate/ Pyruvate ratio
Description
no changes
Time Frame
1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: nonpenetrating traumatic brain injury Glasgow coma scale <9 at presentation Intracranial pressure monitoring brain tissue oxygen tension monitoring and/or microdialysis monitoring invasive mechanical ventilation with FIO2 <60% and PEEP <15 mbar Exclusion Criteria: decompressive craniectomy pregnancy pre-existing neurological disease previous traumatic brain injury acute cardiovascular disease severe respiratory failure acute on chronic liver disease sepsis failure to obtain satisfactory bilateral TCCD signals persisting hypovolemia or hemodynamic instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Steiger, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8006
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34364365
Citation
Klinzing S, Stretti F, Pagnamenta A, Bechir M, Brandi G. Transcranial color-coded duplex sonography assessment of cerebrovascular reactivity to carbon dioxide: an interventional study. BMC Neurol. 2021 Aug 7;21(1):305. doi: 10.1186/s12883-021-02310-9.
Results Reference
derived
PubMed Identifier
30760295
Citation
Brandi G, Stocchetti N, Pagnamenta A, Stretti F, Steiger P, Klinzing S. Cerebral metabolism is not affected by moderate hyperventilation in patients with traumatic brain injury. Crit Care. 2019 Feb 13;23(1):45. doi: 10.1186/s13054-018-2304-6.
Results Reference
derived

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Hyperventilation in Patients With Traumatic Brain Injury

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