Hyperventilation in Patients With Traumatic Brain Injury

Hyperventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822026
• Other study ID #: KEK-ZH 2012-0542 (1)
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Head Injury Trauma
• Hyperventilation
• Wounds and Injuries

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