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

September 27, 2023 updated by: Duzce University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Düzce
      • Duzce, Düzce, Turkey, 81000
        • Recruiting
        • Duzce University Faculty of Medicine
        • Contact:
        • Sub-Investigator:
          • Derya Guclu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cervical blood flow measurement will be performed 3 times in 30 minute period.
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.
Optic nerve sheath diameter measurement will be performed 3 times in 30 minute period.
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.
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
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.
Montreal cognitive assessment test will be performed 2 times in 30 minute period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duzce University

Investigators

  • Principal Investigator: Özlem Ersoy Karka, Duzce University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drozlemersoy2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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