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

NCT ID: NCT05576857

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2024-03-20

Brief 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. 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.

Conditions

Hyperextension Injury of Neck

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Doppler ultrasonography

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.

Intervention Type: OTHER

Other Intervention Names

Montreal cognitive assessment test; cerebral oximeter

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Özlem Ersoy Karka

Role: PRINCIPAL_INVESTIGATOR

Düzce University Faculty of Medicine

Locations

Duzce University Faculty of Medicine

Düzce, Düzce, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

drozlemersoy2

Identifier Type: -

Identifier Source: org_study_id