Hyperextension Injury of NeckNCT05576857
Effects of Cervical Hyperextension on Cervical Blood Flow, Cerebral Oximetry and Cognitive Functions.
An observational study of Hyperextension Injury of Neck, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the effects of cervical hyperextension on cerebral oximetry and cognitive functions in healthy individuals without other additional factors such as anesthesia and surgical stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperextension Injury of Neck
- What is being tested?
- Doppler ultrasonography
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2021to 20 Mar 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 55 healthy volunteers between age of 18-65 years who meet the specified criteria, agreed to participate and signed informed consent will be included in the study.
Who may be able to join
- 18-65 years, healthy volunteers
Who cannot join
- diabetes mellitus,
- chronic obstructive pulmonary disease,
- Liver failure,
- Kidney failure,
- Past coronary arteria by-pass graft history,
- Hemoglobinopathies,
Show all 12Show fewer
- Anemia,
- hypertensive patients,
- Alzheimer's disease,
- neurodegenerative diseases,
- mental retardation,
- Vertebrobasilar system anomalies detected in magnetic resonance-angiography
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine
Düzce, Düzce, 81000
About this study
Official title: The Effects of Neck Hyperextension on Neck Blood Flow, Cerebral Oximetry and Cognitive Functions in Adult Healthy Volunteers
The goal of this observational study is to determine the effects of cervical hyperextension on cerebral oximetry and cognitive functions in healthy individuals without other additional factors such as anesthesia and surgical stress. The main questions it aims to answer are:
- Can cervical hyperextension cause changes in cerebral oxygenation in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in cervical and cerebral blood flow in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in cognitive functions in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in optic nerve sheath diameter in non-anesthetized healthy individuals? Participants will be monitored with cerebral oximeter device and asked to answer Montreal cognitive function test before and during cervical hyperextension position. The researchers will evaluate the changes in cervical and cerebral blood flow ultrasonographically before and during cervical hyperextension position.
Read the detailed description
Some operations are performed in the cervical hyperextension position. During the cervical hyperextension position, changes in neck blood flow as a result of stretching of neck vessels can occur. These changes can be observed as an increase or decrease in cerebral blood flow. Changes in cerebral blood flow can lead to changes in brain oxygenation and affect cognitive functions.
Aim: This study aims to show the effects of cervical hyperextension on cerebral oximetry and cognitive functions in healthy individuals without other additional factors such as anesthesia and surgical stress.
Method: Healthy volunteers who meet the specified criteria and sign informed consent will be included in the study. All volunteers will be asked to answer validated Montreal cognitive assessment test in Turkish. Cerebral oximetry will be monitored by 2 probes placed on the frontal bone while all volunteers are lying in a supine position with the neck in a neutral position. Basal cerebral oximetry values will be recorded. In the same position cervical blood flow values and optic nerve sheath diameter will be measured by the same and experienced researcher non-invasively with a Doppler ultrasonography device and recorded. Optimum cervical hyperextension position will be obtained by placing the standard pad under the neck of the volunteers. In the meantime cerebral oximetry values will be recorded. Cervical blood flow will be re-measured in this position non-invasively with a Doppler ultrasonography device and recorded. Cerebral oximeter values will be recorded every 5 minutes for 30 minutes. In the end of 30 minutes period of hyperextension position the cervical blood flow and optic nerve sheath diameter will be measured again non-invasively with a Doppler ultrasonography device and recorded. Immediately afterwards, the Montreal cognitive assessment test will be repeated without changing the position. After all measurements are completed, the procedure will be terminated by resting the volunteer in neutral position for 15 minutes.
- Conditions
- Hyperextension Injury of Neck
- Being tested
- Doppler ultrasonography
- Keywords
- hyperextension of neck, cervical blood flow, cerebral oxygen saturation, optic nerve sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyOther
Also called Montreal cognitive assessment test, cerebral oximeter
All volunteers will be monitored with cerebral oximeter, asked to answer the Montreal cognitive assessment test and cervical blood flow values and optic nerve sheath diameter will be determined with Doppler ultrasonography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the cervical blood flow rates
Cervical blood flow measurement will be performed 3 times by the same and experienced researcher with the same Doppler ultrasonography device; before cervical hyperextension in neutral position, in the first 5 minutes of cervical hyperextension, in the end of 30 minutes period of cervical hyperextension position.
Measured: Cervical blood flow measurement will be performed 3 times in 30 minute period.
Change from baseline in the optic nerve sheath diameter
Optic nerve sheath diameter measurement will be performed 2 times by the same and experienced researcher with the same Doppler ultrasonography device:
before cervical hyperextension in neutral position, in the end of 30 minutes period of cervical hyperextension position.
Measured: Optic nerve sheath diameter measurement will be performed 3 times in 30 minute period.
Change from baseline in the cerebral oximeter values
Cerebral oxygenisation values will be measured continuously before and during the cervical hyperextension position with a transcutaneous near infrared spectroscope device (NIRS) via two transcutaneous probes placed on the frontal bone non-invasively and recorded.
Measured: Cerebral oxygenisation values will be measured continuously before and during the cervical hyperextension position and recorded in every 5 minutes in 30 minute period.
Change from baseline in the Montreal cognitive assessment test
All volunteers will be asked to answer the Montreal cognitive assessment test 2 times by the same researcher; before cervical hyperextension in neutral position, in the end of 30 minutes period of cervical hyperextension position.
Measured: Montreal cognitive assessment test will be performed 2 times in 30 minute period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start29 Mar 2021
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperextension Injury of NeckStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Özlem Ersoy Karka, Principal investigator, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576857
- Sponsor's protocol ID
- drozlemersoy2
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neck Hyperextension on Neck Blood Flow, Cerebral Oximetry and Cognitive Functions in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05576857
- Acronym / sponsor ID
- drozlemersoy2
- Conditions
- Hyperextension Injury of Neck
- Keywords
- hyperextension of neck, cervical blood flow, cerebral oxygen saturation, optic nerve sheath
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 13 Oct 2022 (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.
The goal of this observational study is to determine the effects of cervical hyperextension on cerebral oximetry and cognitive functions in healthy individuals without other additional factors such as anesthesia and surgical stress. The main questions it aims to answer are:
- Can cervical hyperextension cause changes in cerebral oxygenation in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in cervical and cerebral blood flow in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in cognitive functions in non-anesthetized healthy individuals?
- Can cervical hyperextension cause changes in optic nerve sheath diameter in non-anesthetized healthy individuals? Participants will be monitored with cerebral oximeter device and asked to answer Montreal cognitive function test before and during cervical hyperextension position. The researchers will evaluate the changes in cervical and cerebral blood flow ultrasonographically before and during cervical hyperextension position.
Detailed description
Some operations are performed in the cervical hyperextension position. During the cervical hyperextension position, changes in neck blood flow as a result of stretching of neck vessels can occur. These changes can be observed as an increase or decrease in cerebral blood flow. Changes in cerebral blood flow can lead to changes in brain oxygenation and affect cognitive functions.
Aim: This study aims to show the effects of cervical hyperextension on cerebral oximetry and cognitive functions in healthy individuals without other additional factors such as anesthesia and surgical stress.
Method: Healthy volunteers who meet the specified criteria and sign informed consent will be included in the study. All volunteers will be asked to answer validated Montreal cognitive assessment test in Turkish. Cerebral oximetry will be monitored by 2 probes placed on the frontal bone while all volunteers are lying in a supine position with the neck in a neutral position. Basal cerebral oximetry values will be recorded. In the same position cervical blood flow values and optic nerve sheath diameter will be measured by the same and experienced researcher non-invasively with a Doppler ultrasonography device and recorded. Optimum cervical hyperextension position will be obtained by placing the standard pad under the neck of the volunteers. In the meantime cerebral oximetry values will be recorded. Cervical blood flow will be re-measured in this position non-invasively with a Doppler ultrasonography device and recorded. Cerebral oximeter values will be recorded every 5 minutes for 30 minutes. In the end of 30 minutes period of hyperextension position the cervical blood flow and optic nerve sheath diameter will be measured again non-invasively with a Doppler ultrasonography device and recorded. Immediately afterwards, the Montreal cognitive assessment test will be repeated without changing the position. After all measurements are completed, the procedure will be terminated by resting the volunteer in neutral position for 15 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 55 healthy volunteers between age of 18-65 years who meet the specified criteria, agreed to participate and signed informed consent will be included in the study.
Key inclusion criteria (1 listed)
- 18-65 years, healthy volunteers
Key exclusion criteria (12 listed)
- diabetes mellitus,
- chronic obstructive pulmonary disease,
- Liver failure,
- Kidney failure,
- Past coronary arteria by-pass graft history,
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 |
|---|---|---|
| Doppler ultrasonographyAlso: Montreal cognitive assessment test, cerebral oximeterAll volunteers will be monitored with cerebral oximeter, asked to answer the Montreal cognitive assessment test and cervical blood flow values and optic nerve sheath diameter will be determined with Doppler ultrasonography. | Other | – |
Primary outcome
Change from baseline in the cervical blood flow rates
Time frame: Cervical blood flow measurement will be performed 3 times in 30 minute period.
Cervical blood flow measurement will be performed 3 times by the same and experienced researcher with the same Doppler ultrasonography device; before cervical hyperextension in neutral position, in the first 5 minutes of cervical hyperextension, in the end of 30 minutes period of cervical hyperextension position.
Change from baseline in the optic nerve sheath diameter
Time frame: Optic nerve sheath diameter measurement will be performed 3 times in 30 minute period.
Optic nerve sheath diameter measurement will be performed 2 times by the same and experienced researcher with the same Doppler ultrasonography device: before cervical hyperextension in neutral position, in the end of 30 minutes period of cervical hyperextension position.
Change from baseline in the cerebral oximeter values
Time frame: Cerebral oxygenisation values will be measured continuously before and during the cervical hyperextension position and recorded in every 5 minutes in 30 minute period.
Cerebral oxygenisation values will be measured continuously before and during the cervical hyperextension position with a transcutaneous near infrared spectroscope device (NIRS) via two transcutaneous probes placed on the frontal bone non-invasively and recorded.
Change from baseline in the Montreal cognitive assessment test
Time frame: Montreal cognitive assessment test will be performed 2 times in 30 minute period.
All volunteers will be asked to answer the Montreal cognitive assessment test 2 times by the same researcher; before cervical hyperextension in neutral position, in the end of 30 minutes period of cervical hyperextension position.
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 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
Özlem Ersoy Karka principal investigator
Düzce University Faculty of Medicine
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 Hyperextension Injury of Neck, run by Duzce University at 1 site in Turkey (Türkiye).
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 12 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 7 Aug 2024. 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 Turkey (Türkiye). 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?
Change from baseline in the cervical blood flow rates (time frame: Cervical blood flow measurement will be performed 3 times in 30 minute period.). The study lists 4 primary outcomes in all. 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 7 Aug 2024.