Hyperventilation in Patients With Traumatic Brain Injury

NCT ID: NCT03822026

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-20
• Study Completion Date: 2017-05-02

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.

Conditions

Head Injury Trauma; Hyperventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Hyperventilation test

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Steiger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34364365 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30760295 (View on PubMed)

Other Identifiers

KEK-ZH 2012-0542 (1)

Identifier Type: -

Identifier Source: org_study_id