- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02152488
Cerebral Blood Flow During Flexion and Rotation of the Cervical Spine (TCDPOS)
Rotation or flexion of the cervical spine is unavoidable during positioning for some surgical procedures as carotid endarterectomy, thyroidectomy and surgery of the shoulder. Rotation or flexion may reduce blood flow in the carotid or vertebral arteries and induce intraoperative cerebral ischemia with impact on the neurological outcome of surgery. Predominantly if the circulus willisii is incomplete because of congenital variation, collateral arteries may not be sufficient to compensate reduced blood flow in one carotid or vertebral artery. This may be aggravated by intraoperative hypotension in limits tolerable under normal conditions but fatal during impairment of vascular conductivity by positioning. The middle cerebral artery (MCA) is a final large scale pathway of cerebral blood flow and hence relevant reduction of flow in the MCA may serve as a surrogate parameter for relevant reduction of cerebral blood flow caused by carotid stretching or narrowing.
Objective of this study is to investigate, if MCA blood flow in normal male and female subjects, aged 18 to 85 years, is reduced in extended and rotated cervical spine position in comparison to neutral position.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- University Hospital Schleswig-Holstein, Campus Kiel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients presenting ambulant for preoperative evaluation for routine surgery.
Exclusion Criteria:
- Cranial spine pathology and cerebral vascular disease.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood flow in middle cerebral artery during rotation of the cervical spine
Time Frame: From measurement of baseline blood flow until measurement of blood flow during rotation to the right and hyperextension of the cervical spine up to 1 hour
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Blood flow in the middle cerebral artery (MCA) was measured bilaterally using a bidirectional multigate 2Mhz pulsed wave Transcranial Doppler in normal and rotated position of the cervical spine.
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From measurement of baseline blood flow until measurement of blood flow during rotation to the right and hyperextension of the cervical spine up to 1 hour
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Collaborators and Investigators
Investigators
- Principal Investigator: Axel Fudickar, Dr., University Hospital Schleswig-Holstein, Campus Kiel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Fudickar4
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