Functional Blood Flow DisorderTCDPOSNCT02152488
Cerebral Blood Flow During Flexion and Rotation of the Cervical Spine
An observational study of Functional Blood Flow Disorder, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Blood Flow Disorder
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 patients presenting in the pre-anaesthesia ambulance of the University Hospital Schleswig-Holstein, Campus Kiel were enrolled in the study. Exclusion criteria were cranial spine pathology and known cerebral vascular disease.
Who may be able to join
- Patients presenting ambulant for preoperative evaluation for routine surgery.
Who cannot join
- Cranial spine pathology and cerebral vascular disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
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.
Read the detailed description
Blood flow in the middle cerebral artery (MCA) was measured bilaterally using a bidirectional multigate 2Mhz pulsed wave Transcranial Doppler (Multidop T1, Software Multiflow MF version 8.27j, DWL Corp., Sipplingen, Germany). Using a trans-temporal approach to the proximal segment (M1) of the MCA, the Doppler probes were fixed bilaterally with an adjustable mounting (SPENCER helmet) to keep the angle and depth of insonation constant over time. With the upper cervical spine in a neutral sagittal orientation, the insonation depth was chosen between 45 and 55 mm and the point permitting best recording was fixed. A sample volume of 5 mm, a sonographic frequency of 128 Hz FFT, and a fast sweep for temporal overlap were determined. Low power and low gain was set within the dynamic range of the system. All measurements were performed between 10:00 AM and 2:00 PM, by the same examiner (JL) in a quiet, warm, well-lit room. Each subject was asked to assume a relaxed, supine position. Patients eyes were closed to eliminate stimulation of the occipital cortex. Three minutes rest were provided to acclimatize and stabilize haemodynamically. Non-invasive blood pressure was measured at both arms before and after the procedure to ensure that any possible changes in blood flow were not related to blood pressure changes. The time-averaged mean blood flow velocities on both sides were measured with the cervical spine in neutral position, rotated maximally to the left, then to the right, hyperextended and then hyperextended and rotated to the left and to the right position. Measurements were performed after 1 min of stable blood flow. Neutral position was reestablished after each position and next maneuver started after blood velocities in neutral position had normalized to velocities in starting neutral position.
- Conditions
- Functional Blood Flow Disorder
- Keywords
- cerebral blood flow, position, cervical spine
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow in middle cerebral artery during rotation of the cervical spine
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Blood Flow DisorderStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Fudickar, University Hospital Schleswig-Holstein
- Investigators
- Axel Fudickar, Dr., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152488
- Sponsor's protocol ID
- Fudickar4
- Acronym
- TCDPOS
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow During Flexion and Rotation of the Cervical Spine
- ClinicalTrials.gov ID
- NCT02152488
- Acronym / sponsor ID
- TCDPOS / Fudickar4
- Conditions
- Functional Blood Flow Disorder
- Keywords
- cerebral blood flow, position, cervical spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Jun 2014 (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.
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.
Detailed description
Blood flow in the middle cerebral artery (MCA) was measured bilaterally using a bidirectional multigate 2Mhz pulsed wave Transcranial Doppler (Multidop T1, Software Multiflow MF version 8.27j, DWL Corp., Sipplingen, Germany). Using a trans-temporal approach to the proximal segment (M1) of the MCA, the Doppler probes were fixed bilaterally with an adjustable mounting (SPENCER helmet) to keep the angle and depth of insonation constant over time. With the upper cervical spine in a neutral sagittal orientation, the insonation depth was chosen between 45 and 55 mm and the point permitting best recording was fixed. A sample volume of 5 mm, a sonographic frequency of 128 Hz FFT, and a fast sweep for temporal overlap were determined. Low power and low gain was set within the dynamic range of the system. All measurements were performed between 10:00 AM and 2:00 PM, by the same examiner (JL) in a quiet, warm, well-lit room. Each subject was asked to assume a relaxed, supine position. Patients eyes were closed to eliminate stimulation of the occipital cortex. Three minutes rest were provided to acclimatize and stabilize haemodynamically. Non-invasive blood pressure was measured at both arms before and after the procedure to ensure that any possible changes in blood flow were not related to blood pressure changes. The time-averaged mean blood flow velocities on both sides were measured with the cervical spine in neutral position, rotated maximally to the left, then to the right, hyperextended and then hyperextended and rotated to the left and to the right position. Measurements were performed after 1 min of stable blood flow. Neutral position was reestablished after each position and next maneuver started after blood velocities in neutral position had normalized to velocities in starting neutral position.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients presenting in the pre-anaesthesia ambulance of the University Hospital Schleswig-Holstein, Campus Kiel were enrolled in the study. Exclusion criteria were cranial spine pathology and known cerebral vascular disease.
Key inclusion criteria (1 listed)
- Patients presenting ambulant for preoperative evaluation for routine surgery.
Key exclusion criteria (1 listed)
- Cranial spine pathology and cerebral vascular disease.
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
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
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.
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 2 Jun 2014.
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.
Axel Fudickar, Dr. principal investigator
University Hospital Schleswig-Holstein
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 Functional Blood Flow Disorder, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 1 inclusion and 1 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 2 Jun 2014. 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 Germany. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.