Head Injury TraumaNCT03822026
Hyperventilation in Patients With Traumatic Brain Injury
A study testing Hyperventilation test in people with Head Injury Trauma and Hyperventilation, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Injury Trauma, Hyperventilation
- What is being tested?
- Hyperventilation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 May 2014to 2 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- decompressive craniectomy
- pregnancy
- pre-existing neurological disease
- previous traumatic brain injury
- acute cardiovascular disease
- severe respiratory failure
Show all 10Show fewer
- acute on chronic liver disease
- sepsis
- failure to obtain satisfactory bilateral TCCD signals
- persisting hypovolemia or hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury
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.
Read the 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
- Being tested
- Hyperventilation test
- Keywords
- intracranial pressure, cerebral metabolism, cerebral oxygenation
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperventilation testOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hyperventilation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure
Change of intracranial pressure during moderate hyperventilation
Measured: 10, 20, 50, 60 minutes after begin of the hyperventilation test
Secondary outcomes (3)
cerebral flow velocity in the middle cerebral artery
Change of cerebral flow velocity during moderate hyperventilation
Measured: 20, 50, 60 minutes after begin of the hyperventilation test
brain tissue oxygenation (PbrO2)
no changes
Measured: 10, 20, 50, 60 minutes after begin of the hyperventilation test
cerebral Lactate/ Pyruvate ratio
no changes
Measured: 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start20 May 2014
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head Injury TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Steiger, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822026
- Sponsor's protocol ID
- KEK-ZH 2012-0542 (1)
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34364365Brandi 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.
PubMed 30760295
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03822026
- Acronym / sponsor ID
- KEK-ZH 2012-0542 (1)
- Conditions
- Head Injury Trauma, Hyperventilation
- Keywords
- intracranial pressure, cerebral metabolism, cerebral oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 May 2014 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline
| Arm | Type | Receives |
|---|---|---|
| patients with severe TBI | Other | Other: Hyperventilation testPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- decompressive craniectomy
- pregnancy
- pre-existing neurological disease
- previous traumatic brain injury
- acute cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperventilation testIncrease 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 | Other | patients with severe TBI |
Primary outcome
intracranial pressure
Time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
Change of intracranial pressure during moderate hyperventilation
3 secondary outcomes
cerebral flow velocity in the middle cerebral artery
Time frame: 20, 50, 60 minutes after begin of the hyperventilation test
brain tissue oxygenation (PbrO2)
Time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
cerebral Lactate/ Pyruvate ratio
Time frame: 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 34364365Klinzing 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.
- Derived from this study: PubMed 30760295Brandi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Steiger, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperventilation test in people with Head Injury Trauma and Hyperventilation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial pressure (time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.