Completed

NCT Number: NCT05576857

Effects of Cervical Hyperextension on Cervical Blood Flow, Cerebral Oximetry and Cognitive Functions.

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.

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Key information

Conditions

Hyperextension Injury of Neck

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University Faculty of Medicine

Düzce, 81000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-65 years, healthy volunteers

Exclusion criteria

diabetes mellitus,
chronic obstructive pulmonary disease,
Liver failure,
Kidney failure,
Past coronary arteria by-pass graft history,
Hemoglobinopathies,
Anemia,
hypertensive patients,
Alzheimer's disease,
neurodegenerative diseases,
mental retardation,
Vertebrobasilar system anomalies detected in magnetic resonance-angiography

Treatment and study plan

Doppler ultrasonography

Other

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.

Other names: Montreal cognitive assessment test, cerebral oximeter

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

The Effects of Neck Hyperextension on Neck Blood Flow, Cerebral Oximetry and Cognitive Functions in Adult Healthy Volunteers

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Oct 13, 2022
Registry last updated: Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.