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CompletedNCT03822026Updated Jan 30, 2019

Hyperventilation in Patients With Traumatic Brain Injury

An interventional study of Hyperventilation test in Head Injury Trauma and Hyperventilation, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled May 2014, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Head Injury Trauma
  • Hyperventilation

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Keywords

  • intracranial pressure
  • cerebral metabolism
  • cerebral oxygenation
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In context

Hyperventilation

43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.

This study's enrollment of 11 is below the median of 40 across 31 interventional studies indexed under Hyperventilation.

Browse Hyperventilation studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Other
    patients with severe TBI

    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.

    Other: Hyperventilation test

Interventions

  • OtherHyperventilation test

    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

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What researchers measure

Primary outcomes

  1. intracranial pressure

    Change of intracranial pressure during moderate hyperventilation

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

Secondary outcomes

  1. cerebral flow velocity in the middle cerebral artery

    Change of cerebral flow velocity during moderate hyperventilation

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

  2. brain tissue oxygenation (PbrO2)

    no changes

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

  3. cerebral Lactate/ Pyruvate ratio

    no changes

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

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Study locations

1 site
  • University Hospital Zurich
    Zürich, 8006, Switzerland
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References and documents

Publications

  • 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. PubMed 34364365 ↗
  • 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. PubMed 30760295 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03822026
Responsible party
Sponsor
First posted
Jan 30, 2019
Start date
May 20, 2014
Primary completion
May 2, 2017
Completion
May 2, 2017
Last update
Jan 30, 2019

Study contacts

Peter Steiger, MD
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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