Thyroid SurgeryNCT06797388
The Effect of Thyroid Lobe Volume on the Common Carotid Artery Blood Flow
An observational study of Thyroid Surgery and Head Extension on the Anatomic Axes of the Superior Airway, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate how thyroid lobe volume affects carotid artery blood flow dynamics in adult patients undergoing elective thyroidectomy. The study includes male and female participants aged 18 years and older who have euthyroid function and are scheduled for elective thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery, Head Extension on the Anatomic Axes of the Superior Airway
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2017to 20 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients scheduled for elective thyroidectomy at a tertiary academic hospital. Participants are drawn from the hospital's general surgery clinic, which serves a diverse population from both urban and surrounding rural areas. Patients undergoing surgery for various thyroid pathologies, including benign nodules and malign pathologies, are included. All participants are assessed preoperatively to ensure they meet the study's inclusion criteria, including euthyroid status, and are representative of individuals typically undergoing elective thyroid surgery in this clinical setting.
Who may be able to join
- Adult patients (≥18 years old) scheduled for elective thyroidectomy.
- Patients in a euthyroid state as confirmed by recent laboratory tests.
- Ability to provide written informed consent.
Who cannot join
- Pregnant patients.
- Emergency thyroidectomy cases.
- History of subtotal thyroidectomy.
- History of allergic reaction to anesthetic agents.
- Presence of anemia (hemoglobin levels below local institutional thresholds).
- Presence of labile hypertension (documented by repeated measurements on the surgical ward)
- Presence of abnormal thyroid hormone levels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Thyroid Lobe Volume on the Common Carotid Artery Blood Flow in Thyroidectomy Position
The goal of this observational study is to evaluate how thyroid lobe volume affects carotid artery blood flow dynamics in adult patients undergoing elective thyroidectomy. The study includes male and female participants aged 18 years and older who have euthyroid function and are scheduled for elective thyroidectomy.
The main questions it aims to answer are:
Read more
- Does thyroid lobe volume influence carotid artery blood flow characteristics, particularly systolic/diastolic flow time ratios, during thyroidectomy?
- What is the optimal thyroid lobe volume cutoff for predicting altered systolic/diastolic flow time ratios (<0.3)?
Participants will:
- Undergo Doppler ultrasound measurements at three time points: before anesthesia induction, after anesthesia induction, and after surgical positioning.
- Have their carotid artery blood flow and regional cerebral oxygenation values assessed.
No comparison groups are involved, as all participants will be observed under the same conditions.
Read the detailed description
This observational study investigates how the size of the thyroid gland affects blood flow in the common carotid artery during thyroidectomy, a surgical procedure to remove part or all of the thyroid gland. The thyroid gland is anatomically close to the carotid artery, a major blood vessel supplying blood to the brain. Enlarged thyroid lobes may compress the artery, potentially altering blood flow dynamics, particularly during the semi-Fowler's position required for the surgery. By examining these effects, this study aims to provide insights into the interplay between thyroid anatomy and carotid blood flow, which could have implications for surgical and anesthetic management.
Study Objectives
The primary objective is to determine the relationship between thyroid lobe volume and carotid artery blood flow during thyroidectomy. Specifically, the study seeks to:
- Evaluate how thyroid lobe volume influences systolic and diastolic blood flow in the carotid artery.
- Identify a thyroid lobe volume cutoff associated with significant alterations in systolic/diastolic flow time ratios (<0.3).
Study Population
The study includes adult patients aged 18 years and older scheduled for elective thyroidectomy. Participants must be in a euthyroid state, as thyroid hormone abnormalities may influence recovery and perioperative outcomes. Patients with conditions such as anemia, labile hypertension, or prior thyroid surgeries, as well as pregnant or emergency cases, are excluded.
Study Design
This is a prospective observational study conducted at a tertiary academic hospital. Measurements are obtained from each participant at three critical time points:
- Baseline (T0): Before anesthesia induction.
- After anesthesia induction (T1).
- After surgical positioning (T2): In the semi-Fowler's position with head extension.
Doppler ultrasound is used to assess carotid artery diameters and flow velocities. Regional cerebral oxygenation is also measured using a cerebral oximeter to evaluate the impact of altered blood flow on brain perfusion.
Study Methods
Participants undergo the following procedures during the study:
- Ultrasound Measurements: The diameters of the common carotid artery at systole and diastole are measured, and Doppler flow velocities (peak systolic velocity, end-diastolic velocity) are recorded. These values are used to calculate mean velocity, Gosling pulsatility index, and Pourcelot resistance index.
- Manual Tracing of VTI: In cases with altered systolic/diastolic flow ratios, manual tracing is used to ensure accuracy.
- Keywords
- common carotid artery, common carotid artery blood flow, Doppler ultrasonography, thyroid volume, cerebral oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal size | Right or left side of any patient with a normal thyroid lobe size according to gender-specific limits of normal thyroid volume (15 ml for adult females, 18 ml for adult males) | |
| Large size | Right or left side of any patient with a large thyroid lobe size according to gender-specific limits of normal thyroid volume (15 ml for adult females, 18 ml for adult males) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic/Diastolic Flow Time Ratio of the Common Carotid Artery
Assess the relationship between thyroid lobe volume and alterations in the systolic/diastolic flow time ratio during thyroidectomy.
Measured: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
Thyroid Lobe Volume Cutoff for Altered Flow Dynamics
Determine the thyroid lobe volume cutoff associated with a systolic/diastolic flow time ratio <0.3.
Measured: Post-hoc analysis using data from baseline (T0).
Secondary outcomes (2)
Change in Carotid Artery Blood Flow
Evaluate how thyroid lobe volume affects carotid artery blood flow during different surgical time points.
Measured: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
Regional Cerebral Oxygenation Changes
Measure the impact of altered carotid artery blood flow on regional cerebral oxygenation during thyroidectomy.
Measured: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start6 Mar 2017
- Primary completion24 Dec 2018
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Erdivanlı, Recep Tayyip Erdogan University
- Investigators
- Başar Erdivanlı, Assoc. Prof., Study director, Recep Tayyip Erdogan University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797388
- Sponsor's protocol ID
- 2016/21
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data supporting the reported results and the R source files used during the analysis will be made available by the authors on reasonable request.
Publications
Braakman HM, Knippenberg SA, de Bondt BJ, Lodder J. An unusual cause of transient neurologic deficits: compression of the carotid artery by a thyroid cystic nodule. J Stroke Cerebrovasc Dis. 2010 Jan;19(1):73-4. doi: 10.1016/j.jstrokecerebrovasdis.2009.02.007.
PubMed 20123230Saracoglu A, Altun D, Yavru A, Aksakal N, Sormaz IC, Camci E. Effects of Head Position on Cerebral Oxygenation and Blood Flow Velocity During Thyroidectomy. Turk J Anaesthesiol Reanim. 2016 Oct;44(5):241-246. doi: 10.5152/TJAR.2016.77598. Epub 2016 Oct 1.
PubMed 27909604
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thyroid Lobe Volume on the Common Carotid Artery Blood Flow in Thyroidectomy Position
- ClinicalTrials.gov ID
- NCT06797388
- Acronym / sponsor ID
- 2016/21
- Keywords
- common carotid artery, common carotid artery blood flow, Doppler ultrasonography, thyroid volume, cerebral oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 28 Jan 2025 (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 evaluate how thyroid lobe volume affects carotid artery blood flow dynamics in adult patients undergoing elective thyroidectomy. The study includes male and female participants aged 18 years and older who have euthyroid function and are scheduled for elective thyroidectomy.
The main questions it aims to answer are:
- Does thyroid lobe volume influence carotid artery blood flow characteristics, particularly systolic/diastolic flow time ratios, during thyroidectomy?
- What is the optimal thyroid lobe volume cutoff for predicting altered systolic/diastolic flow time ratios (<0.3)?
Participants will:
- Undergo Doppler ultrasound measurements at three time points: before anesthesia induction, after anesthesia induction, and after surgical positioning.
- Have their carotid artery blood flow and regional cerebral oxygenation values assessed.
No comparison groups are involved, as all participants will be observed under the same conditions.
Detailed description
This observational study investigates how the size of the thyroid gland affects blood flow in the common carotid artery during thyroidectomy, a surgical procedure to remove part or all of the thyroid gland. The thyroid gland is anatomically close to the carotid artery, a major blood vessel supplying blood to the brain. Enlarged thyroid lobes may compress the artery, potentially altering blood flow dynamics, particularly during the semi-Fowler's position required for the surgery. By examining these effects, this study aims to provide insights into the interplay between thyroid anatomy and carotid blood flow, which could have implications for surgical and anesthetic management.
Study Objectives
The primary objective is to determine the relationship between thyroid lobe volume and carotid artery blood flow during thyroidectomy. Specifically, the study seeks to:
- Evaluate how thyroid lobe volume influences systolic and diastolic blood flow in the carotid artery.
- Identify a thyroid lobe volume cutoff associated with significant alterations in systolic/diastolic flow time ratios (<0.3).
Study Population
The study includes adult patients aged 18 years and older scheduled for elective thyroidectomy. Participants must be in a euthyroid state, as thyroid hormone abnormalities may influence recovery and perioperative outcomes. Patients with conditions such as anemia, labile hypertension, or prior thyroid surgeries, as well as pregnant or emergency cases, are excluded.
Study Design
This is a prospective observational study conducted at a tertiary academic hospital. Measurements are obtained from each participant at three critical time points:
- Baseline (T0): Before anesthesia induction.
- After anesthesia induction (T1).
- After surgical positioning (T2): In the semi-Fowler's position with head extension.
Doppler ultrasound is used to assess carotid artery diameters and flow velocities. Regional cerebral oxygenation is also measured using a cerebral oximeter to evaluate the impact of altered blood flow on brain perfusion.
Study Methods
Participants undergo the following procedures during the study:
- Ultrasound Measurements: The diameters of the common carotid artery at systole and diastole are measured, and Doppler flow velocities (peak systolic velocity, end-diastolic velocity) are recorded. These values are used to calculate mean velocity, Gosling pulsatility index, and Pourcelot resistance index.
- Manual Tracing of VTI: In cases with altered systolic/diastolic flow ratios, manual tracing is used to ensure accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal size | – | –Right or left side of any patient with a normal thyroid lobe size according to gender-specific limits of normal thyroid volume (15 ml for adult females, 18 ml for adult males) |
| Large size | – | –Right or left side of any patient with a large thyroid lobe size according to gender-specific limits of normal thyroid volume (15 ml for adult females, 18 ml for adult males) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients scheduled for elective thyroidectomy at a tertiary academic hospital. Participants are drawn from the hospital's general surgery clinic, which serves a diverse population from both urban and surrounding rural areas. Patients undergoing surgery for various thyroid pathologies, including benign nodules and malign pathologies, are included. All participants are assessed preoperatively to ensure they meet the study's inclusion criteria, including euthyroid status, and are representative of individuals typically undergoing elective thyroid surgery in this clinical setting.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old) scheduled for elective thyroidectomy.
- Patients in a euthyroid state as confirmed by recent laboratory tests.
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Pregnant patients.
- Emergency thyroidectomy cases.
- History of subtotal thyroidectomy.
- History of allergic reaction to anesthetic agents.
- Presence of anemia (hemoglobin levels below local institutional thresholds).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Systolic/Diastolic Flow Time Ratio of the Common Carotid Artery
Time frame: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
Assess the relationship between thyroid lobe volume and alterations in the systolic/diastolic flow time ratio during thyroidectomy.
Thyroid Lobe Volume Cutoff for Altered Flow Dynamics
Time frame: Post-hoc analysis using data from baseline (T0).
Determine the thyroid lobe volume cutoff associated with a systolic/diastolic flow time ratio <0.3.
2 secondary outcomes
Change in Carotid Artery Blood Flow
Time frame: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
Regional Cerebral Oxygenation Changes
Time frame: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).
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 28 Jan 2025.
- Background: PubMed 20123230Braakman HM, Knippenberg SA, de Bondt BJ, Lodder J. An unusual cause of transient neurologic deficits: compression of the carotid artery by a thyroid cystic nodule. J Stroke Cerebrovasc Dis. 2010 Jan;19(1):73-4. doi: 10.1016/j.jstrokecerebrovasdis.2009.02.007.
- Background: PubMed 27909604Saracoglu A, Altun D, Yavru A, Aksakal N, Sormaz IC, Camci E. Effects of Head Position on Cerebral Oxygenation and Blood Flow Velocity During Thyroidectomy. Turk J Anaesthesiol Reanim. 2016 Oct;44(5):241-246. doi: 10.5152/TJAR.2016.77598. Epub 2016 Oct 1.
- Individual participant dataSharing planned: Yes. The raw data supporting the reported results and the R source files used during the analysis will be made available by the authors on reasonable request.
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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.
Başar Erdivanlı, Assoc. Prof. study director
Recep Tayyip Erdogan University Medical Faculty
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 Thyroid Surgery and Head Extension on the Anatomic Axes of the Superior Airway, run by Recep Tayyip Erdogan 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 3 inclusion and 7 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 28 Jan 2025. 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 in Systolic/Diastolic Flow Time Ratio of the Common Carotid Artery (time frame: Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06797388, which also lists 2 linked publications.
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 28 Jan 2025.