Hyperventilation in Patients With Traumatic Brain Injury

NCT03822026 | Completed

• 1 other identifier: KEK-ZH 2012-0542 (1)
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injury Trauma; Hyperventilation

Keywords

intracranial pressure; cerebral metabolism; cerebral oxygenation

Outcome Measures

Primary Outcomes (1)

• intracranial pressure

  Change of intracranial pressure during moderate hyperventilation

  10, 20, 50, 60 minutes after begin of the hyperventilation test

Secondary Outcomes (3)

• cerebral flow velocity in the middle cerebral artery

  20, 50, 60 minutes after begin of the hyperventilation test

• brain tissue oxygenation (PbrO2)

  10, 20, 50, 60 minutes after begin of the hyperventilation test

• cerebral Lactate/ Pyruvate ratio

  1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test

Study Arms (1)

patients with severe TBI

OTHER

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.

Other: Hyperventilation test

Interventions

Hyperventilation test 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

patients with severe TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8006, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 34364365 DERIVED

• 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.

  PMID: 30760295 DERIVED

MeSH Terms

Conditions

Hyperventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Steiger, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 30, 2019
• Study Start: May 20, 2014
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CH (1)