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Completed

NCT Number: NCT03822026

Hyperventilation in Patients With Traumatic Brain Injury

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.

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Key information

Conditions

Head Injury Trauma Hyperventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8006, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperventilation test

Other

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 outcomes

  1. intracranial pressure

    Time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test

    Change of intracranial pressure during moderate hyperventilation

Secondary outcomes

  1. cerebral flow velocity in the middle cerebral artery

    Time frame: 20, 50, 60 minutes after begin of the hyperventilation test

    Change of cerebral flow velocity during moderate hyperventilation

  2. brain tissue oxygenation (PbrO2)

    Time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test

    no changes

  3. cerebral Lactate/ Pyruvate ratio

    Time frame: 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test

    no changes

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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