Hyperventilation in Patients With Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Head Injury Trauma; Hyperventilation
• Interventions: Other: Hyperventilation test

• Registration Number: NCT03822026
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2014-05-20
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with severe TBI	Hyperventilation test	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.

Primary Outcome Measures

Name	Time	Method
intracranial pressure	10, 20, 50, 60 minutes after begin of the hyperventilation test	Change of intracranial pressure during moderate hyperventilation

Secondary Outcome Measures

Name	Time	Method
cerebral flow velocity in the middle cerebral artery	20, 50, 60 minutes after begin of the hyperventilation test	Change of cerebral flow velocity during moderate hyperventilation
brain tissue oxygenation (PbrO2)	10, 20, 50, 60 minutes after begin of the hyperventilation test	no changes
cerebral Lactate/ Pyruvate ratio	1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test	no changes

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland