Clinical trial NCT03822026: Hyperventilation in Patients With Traumatic Brain Injury
Official title: Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury Trauma
Hyperventilation
Keywords: intracranial pressure
cerebral metabolism
cerebral oxygenation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: intracranial pressure
timeFrame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
Secondary outcomes:
measure: cerebral flow velocity in the middle cerebral artery
timeFrame: 20, 50, 60 minutes after begin of the hyperventilation test
measure: brain tissue oxygenation (PbrO2)
timeFrame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
measure: cerebral Lactate/ Pyruvate ratio
timeFrame: 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Peter Steiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.