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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03822026
Other study ID # KEK-ZH 2012-0542 (1)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2014
Est. completion date May 2, 2017

Study information

Verified date January 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date May 2, 2017
Est. primary completion date May 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Hyperventilation 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

Locations

Country Name City State
Switzerland University Hospital Zurich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary intracranial pressure Change of intracranial pressure during moderate hyperventilation 10, 20, 50, 60 minutes after begin of the hyperventilation test
Secondary cerebral flow velocity in the middle cerebral artery Change of cerebral flow velocity during moderate hyperventilation 20, 50, 60 minutes after begin of the hyperventilation test
Secondary brain tissue oxygenation (PbrO2) no changes 10, 20, 50, 60 minutes after begin of the hyperventilation test
Secondary cerebral Lactate/ Pyruvate ratio no changes 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test
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