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

NCT05576857 | Completed

• 1 other identifier: drozlemersoy2
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperextension Injury of Neck

Keywords

hyperextension of neck; cervical blood flow; cerebral oxygen saturation; optic nerve sheath

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Montreal cognitive assessment test will be performed 2 times in 30 minute period.

Interventions

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.

Also known as: Montreal cognitive assessment test, cerebral oximeter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• years, healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine

Düzce, Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Özlem Ersoy Karka

  Düzce University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: March 29, 2021
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

TU (1)