Head InjuryNCT00886054
The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients
An observational study of Head Injury and Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Head Injury, Intracerebral Hemorrhage, Ischemic Stroke
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Dec 2010
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted via emergency room for neurosurgical emergency, such as trauma, stroke, etc.
Who may be able to join
- Aged 16 to 80 years
- Neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring
Who cannot join
- associated with multiple organ impairment or failure
- single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure
- associated with severe infection or sepsis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Traumatology, National Taiwain University Hospital
Taipei, Taipei, 10002
About this study
The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.
Read the detailed description
Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.
- Conditions
- Head Injury, Intracerebral Hemorrhage, Ischemic Stroke, Subarachnoid Hemorrhage, Brain Tumor, Hydrocephalus
- Keywords
- Transcranial Doppler, Transcranial color-coded duplex sonography, Neurocritical patients
- Medical subject headings
- Craniocerebral Trauma, Cerebral Hemorrhage, Ischemic Stroke, Subarachnoid Hemorrhage, Brain Neoplasms, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurocritical patients | Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Yi-Hsin Tsai, M.D., Principal investigator, Department of Traumatology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886054
- Sponsor's protocol ID
- 200901010R
- Other IDs
- 97WFA0102463
- Status last verified
- Dec 2009
- First submitted
- 20 Apr 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Aaslid R, Markwalder TM, Nornes H. Noninvasive transcranial Doppler ultrasound recording of flow velocity in basal cerebral arteries. J Neurosurg. 1982 Dec;57(6):769-74. doi: 10.3171/jns.1982.57.6.0769.
PubMed 7143059Berland LL, Bryan CR, Sekar BC, Moss CN. Sonographic examination of the adult brain. J Clin Ultrasound. 1988 Jun;16(5):337-45. doi: 10.1002/jcu.1870160508.
PubMed 3152391Bogdahn U, Becker G, Winkler J, Greiner K, Perez J, Meurers B. Transcranial color-coded real-time sonography in adults. Stroke. 1990 Dec;21(12):1680-8. doi: 10.1161/01.str.21.12.1680.
PubMed 2264074Bor-Seng-Shu E, Hirsch R, Teixeira MJ, De Andrade AF, Marino R Jr. Cerebral hemodynamic changes gauged by transcranial Doppler ultrasonography in patients with posttraumatic brain swelling treated by surgical decompression. J Neurosurg. 2006 Jan;104(1):93-100. doi: 10.3171/jns.2006.104.1.93.
PubMed 16509152Baussart B, Cheisson G, Compain M, Leblanc PE, Tadie M, Benhamou D, Duranteau J. Multimodal cerebral monitoring and decompressive surgery for the treatment of severe bacterial meningitis with increased intracranial pressure. Acta Anaesthesiol Scand. 2006 Jul;50(6):762-5. doi: 10.1111/j.1399-6576.2006.01038.x.
PubMed 16987375Mitchell P, Gregson BA, Vindlacheruvu RR, Mendelow AD. Surgical options in ICH including decompressive craniectomy. J Neurol Sci. 2007 Oct 15;261(1-2):89-98. doi: 10.1016/j.jns.2007.04.040. Epub 2007 Jun 4.
PubMed 17543995Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touze E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser MG; DECIMAL Investigators. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke. 2007 Sep;38(9):2506-17. doi: 10.1161/STROKEAHA.107.485235. Epub 2007 Aug 9.
PubMed 17690311Tang SC, Huang SJ, Jeng JS, Yip PK. Third ventricle midline shift due to spontaneous supratentorial intracerebral hemorrhage evaluated by transcranial color-coded sonography. J Ultrasound Med. 2006 Feb;25(2):203-9. doi: 10.7863/jum.2006.25.2.203.
PubMed 16439783Schmidt B, Klingelhofer J, Schwarze JJ, Sander D, Wittich I. Noninvasive prediction of intracranial pressure curves using transcranial Doppler ultrasonography and blood pressure curves. Stroke. 1997 Dec;28(12):2465-72. doi: 10.1161/01.str.28.12.2465.
PubMed 9412634McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.
PubMed 9761044Newell DW, Aaslid R, Stooss R, Seiler RW, Reulen HJ. Evaluation of hemodynamic responses in head injury patients with transcranial Doppler monitoring. Acta Neurochir (Wien). 1997;139(9):804-17. doi: 10.1007/BF01411398.
PubMed 9351985Shiogai T, Sato E, Tokitsu M, Hara M, Takeuchi K. Transcranial Doppler monitoring in severe brain damage: relationships between intracranial haemodynamics, brain dysfunction and outcome. Neurol Res. 1990 Dec;12(4):205-13. doi: 10.1080/01616412.1990.11739944.
PubMed 1982161Marti-Fabregas J, Belvis R, Guardia E, Cocho D, Munoz J, Marruecos L, Marti-Vilalta JL. Prognostic value of Pulsatility Index in acute intracerebral hemorrhage. Neurology. 2003 Oct 28;61(8):1051-6. doi: 10.1212/01.wnl.0000090520.67254.14.
PubMed 14581663Bouma GJ, Muizelaar JP. Cerebral blood flow in severe clinical head injury. New Horiz. 1995 Aug;3(3):384-94.
PubMed 7496746Manno EM. Transcranial Doppler ultrasonography in the neurocritical care unit. Crit Care Clin. 1997 Jan;13(1):79-104. doi: 10.1016/s0749-0704(05)70297-9.
PubMed 9012577
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients
- ClinicalTrials.gov ID
- NCT00886054
- Acronym / sponsor ID
- 200901010R
- Conditions
- Head Injury, Intracerebral Hemorrhage, Ischemic Stroke, Subarachnoid Hemorrhage, Brain Tumor, Hydrocephalus
- Keywords
- Transcranial Doppler, Transcranial color-coded duplex sonography, Neurocritical patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 22 Apr 2009 (estimated)
- 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.
The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.
Detailed description
Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocritical patients | – | –Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted via emergency room for neurosurgical emergency, such as trauma, stroke, etc.
Key inclusion criteria (2 listed)
- Aged 16 to 80 years
- Neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring
Key exclusion criteria (3 listed)
- associated with multiple organ impairment or failure
- single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure
- associated with severe infection or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Background: PubMed 7143059Aaslid R, Markwalder TM, Nornes H. Noninvasive transcranial Doppler ultrasound recording of flow velocity in basal cerebral arteries. J Neurosurg. 1982 Dec;57(6):769-74. doi: 10.3171/jns.1982.57.6.0769.
- Background: PubMed 3152391Berland LL, Bryan CR, Sekar BC, Moss CN. Sonographic examination of the adult brain. J Clin Ultrasound. 1988 Jun;16(5):337-45. doi: 10.1002/jcu.1870160508.
- Background: PubMed 2264074Bogdahn U, Becker G, Winkler J, Greiner K, Perez J, Meurers B. Transcranial color-coded real-time sonography in adults. Stroke. 1990 Dec;21(12):1680-8. doi: 10.1161/01.str.21.12.1680.
- Background: PubMed 16509152Bor-Seng-Shu E, Hirsch R, Teixeira MJ, De Andrade AF, Marino R Jr. Cerebral hemodynamic changes gauged by transcranial Doppler ultrasonography in patients with posttraumatic brain swelling treated by surgical decompression. J Neurosurg. 2006 Jan;104(1):93-100. doi: 10.3171/jns.2006.104.1.93.
- Background: PubMed 16987375Baussart B, Cheisson G, Compain M, Leblanc PE, Tadie M, Benhamou D, Duranteau J. Multimodal cerebral monitoring and decompressive surgery for the treatment of severe bacterial meningitis with increased intracranial pressure. Acta Anaesthesiol Scand. 2006 Jul;50(6):762-5. doi: 10.1111/j.1399-6576.2006.01038.x.
- Background: PubMed 17543995Mitchell P, Gregson BA, Vindlacheruvu RR, Mendelow AD. Surgical options in ICH including decompressive craniectomy. J Neurol Sci. 2007 Oct 15;261(1-2):89-98. doi: 10.1016/j.jns.2007.04.040. Epub 2007 Jun 4.
- Background: PubMed 17690311Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touze E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser MG; DECIMAL Investigators. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke. 2007 Sep;38(9):2506-17. doi: 10.1161/STROKEAHA.107.485235. Epub 2007 Aug 9.
- Background: PubMed 16439783Tang SC, Huang SJ, Jeng JS, Yip PK. Third ventricle midline shift due to spontaneous supratentorial intracerebral hemorrhage evaluated by transcranial color-coded sonography. J Ultrasound Med. 2006 Feb;25(2):203-9. doi: 10.7863/jum.2006.25.2.203.
- Background: PubMed 9412634Schmidt B, Klingelhofer J, Schwarze JJ, Sander D, Wittich I. Noninvasive prediction of intracranial pressure curves using transcranial Doppler ultrasonography and blood pressure curves. Stroke. 1997 Dec;28(12):2465-72. doi: 10.1161/01.str.28.12.2465.
- Background: PubMed 9761044McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.
- Background: PubMed 9351985Newell DW, Aaslid R, Stooss R, Seiler RW, Reulen HJ. Evaluation of hemodynamic responses in head injury patients with transcranial Doppler monitoring. Acta Neurochir (Wien). 1997;139(9):804-17. doi: 10.1007/BF01411398.
- Background: PubMed 1982161Shiogai T, Sato E, Tokitsu M, Hara M, Takeuchi K. Transcranial Doppler monitoring in severe brain damage: relationships between intracranial haemodynamics, brain dysfunction and outcome. Neurol Res. 1990 Dec;12(4):205-13. doi: 10.1080/01616412.1990.11739944.
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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.
Yi-Hsin Tsai, M.D. principal investigator
Department of Traumatology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Dec 2009. 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 Taiwan. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886054, which also lists 22 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 23 Dec 2009.