The Effect of Thyroid Lobe Volume on the Common Carotid Artery Blood Flow

NCT06797388 | Completed

• 1 other identifier: 2016/21
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thyroid Surgery; Head Extension on the Anatomic Axes of the Superior Airway

Keywords

common carotid artery; common carotid artery blood flow; Doppler ultrasonography; thyroid volume; cerebral oxygenation

Outcome Measures

Primary Outcomes (2)

• 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 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.

  Post-hoc analysis using data from baseline (T0).

Secondary Outcomes (2)

• Change in Carotid Artery Blood Flow

  Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).

• Regional Cerebral Oxygenation Changes

  Measured at baseline (T0), post-anesthesia induction (T1), and post-surgical positioning (T2).

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53020, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 20123230 BACKGROUND

• Saracoglu 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.

  PMID: 27909604 BACKGROUND

Study Officials

• Başar Erdivanlı, Assoc. Prof.

  Recep Tayyip Erdogan University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 6, 2017
• Primary Completion: December 24, 2018
• Study Completion: March 20, 2020
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The individual participant data (IPD) and supporting information, including the study protocol, statistical analysis plan, and analytic code, will be available starting 6 months after publication of the study results. Data will remain available indefinitely for academic purposes.
• Access Criteria: Access to the IPD and supporting information will be provided upon reasonable request to researchers affiliated with academic institutions. Requestors must provide proof of academic affiliation and a clear statement of their intended use of the data. Requests will be reviewed by the corresponding author to ensure alignment with the study's objectives and ethical considerations. Data will be shared through secure data transfer mechanisms.

Locations

TU (1)