Blood PressureNCT06590064
The Relationship Between Upper and Lower Extremity Blood Pressure in Thyroid Surgery Patients Under General Anesthesia
An observational study of Blood Pressure and Diseases of the Thyroid Gland, run by Ilsan Cha hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to clarify the relationship between upper and lower limb blood pressure in thyroid surgery patients under general anesthesia. The hemodynamic state during anesthesia is different from that during the awake state. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Blood Pressure, Diseases of the Thyroid Gland
- What is being tested?
- Non-invasive Blood Pressure Measurement
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2024to 31 Dec 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving elective thyroid surgery under general anesthesia
Who may be able to join
- Patients having elective thyroid surgery under general anesthesia
- Aged between 20 to 80 years old
- American Society of Anesthesiologist(ASA) Physical Status Class I or II
- Individuals who have voluntarily given written consent to participate in this clinical study
Who cannot join
- Patients with Diabetes Mellitus or Peripheral vascular disease
- Patients with a history of Heart disease; Myocardial infarction, Heart failure, etc.
- Patients with Arrhythmia
- Patients with musculoskeletal abnormalities
- Patients for whom the placement of a non-invasive blood pressure cuff is contraindicated: inflammatory diseases or wounds causing pain at the cuff site, severe edema, thrombophlebitis, etc.
- Other cases deemed unsuitable for the study by the researcher: absence of appropriately sized blood pressure cuffs, placement of a pressurized blood pressure cuff expected to affect the induction and maintenance of general anesthesia, history of mental illness, etc.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to clarify the relationship between upper and lower limb blood pressure in thyroid surgery patients under general anesthesia. The hemodynamic state during anesthesia is different from that during the awake state. Therefore, to assess whether the difference in blood pressure between the upper and lower limbs observed in the awake state is consistent with that observed under general anesthesia, the investigators will compare the inter-limb blood pressure differences before anesthesia induction and during general anesthesia.
Read the detailed description
Non-invasive blood pressure measurement during surgery is typically conducted on the upper arm, and previous studies about the relationship between intraoperative blood pressure fluctuation and postoperative mortality and morbility have also based on the upper arm measurements. However, in clinical practice, if monitoring blood pressure in the upper arm is not feasible during surgery, the cuff usually be placed on the ankle.
According to a previous study, the systolic blood pressure at the ankle is approximately 17.0 mmHg higher than the systolic blood pressure at the arm in the supine position (95% CI 15.4-21.3 mmHg), while the diastolic blood pressure did not show significant differences in awake state. Since the hemodynamic state of patients under anesthesia differs from that of awake patients, there is insufficient evidence to directly apply the known differences between upper and lower limb blood pressures in awake patients to set target blood pressure ranges during anesthesia. As a result, anesthesiologists often rely on clinical judgment in these situations.
Therefore, this study sets the null hypothesis that 'the differences in blood pressure between the upper and lower limbs before and after anesthesia are the same.' The goal is to determine whether the previously known relationship between upper and lower limb blood pressures in awake patients can be applied to patients under general anesthesia. Additionally, this study aims to investigate the relationship between upper and lower limb blood pressures when the lower limb blood pressure is outside the normal range during general anesthesia.
- Conditions
- Blood Pressure, Diseases of the Thyroid Gland
- Being tested
- Non-invasive Blood Pressure Measurement
- Keywords
- General anesthesia, Thyroid surgery, Lower extremity blood pressure
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Blood Pressure MeasurementDevice
Non-invasive Blood Pressure Measurement in Both Upper and Lower Limbs
| Study group | Role | What they receive |
|---|---|---|
| Group T | Thyroid surgery patients under general anesthesia Receives: Device: Non-invasive Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
d_MBP(awake)
Difference between upper and lower extremities mean blood pressure in awake state
Measured: Simultaneously measured values in operating room before anesthesia induction
d_MBP(GA)
Difference between upper and lower extremities mean blood pressure during general anesthesia
Measured: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
Secondary outcomes (4)
d_SBP(awake)
Difference between upper and lower extremities systolic blood pressure in awake state
Measured: Simultaneously measured values in operating room before anesthesia induction
d_SBP(GA)
Difference between upper and lower extremities systolic blood pressure during general anesthesia
Measured: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
d_DBP(awake)
Difference between upper and lower extremities diastolic blood pressure in awake state
Measured: Simultaneously measured values in operating room before anesthesia induction
d_DBP(GA)
Difference between upper and lower extremities diastolic blood pressure during general anesthesia
Measured: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jul 2024
- Primary completion25 Mar 2025
- Study completion31 Dec 2025
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 Blood PressureStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, Jee Young Lee, CHA University
- Investigators
- JOOHYUN LEE, Principal investigator, Department of Anesthesia and Pain medicine, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590064
- Sponsor's protocol ID
- ICICC-OS-24-02
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
PubMed 34916049Sheppard JP, Albasri A, Franssen M, Fletcher B, Pealing L, Roberts N, Obeid A, Pucci M, McManus RJ, Martin U; British and Irish Hypertension Society. Defining the relationship between arm and leg blood pressure readings: a systematic review and meta-analysis. J Hypertens. 2019 Apr;37(4):660-670. doi: 10.1097/HJH.0000000000001958.
PubMed 30817444
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Upper and Lower Extremity Blood Pressure in Thyroid Surgery Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06590064
- Acronym / sponsor ID
- ICICC-OS-24-02
- Conditions
- Blood Pressure, Diseases of the Thyroid Gland
- Keywords
- General anesthesia, Thyroid surgery, Lower extremity blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (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 clarify the relationship between upper and lower limb blood pressure in thyroid surgery patients under general anesthesia. The hemodynamic state during anesthesia is different from that during the awake state. Therefore, to assess whether the difference in blood pressure between the upper and lower limbs observed in the awake state is consistent with that observed under general anesthesia, the investigators will compare the inter-limb blood pressure differences before anesthesia induction and during general anesthesia.
Detailed description
Non-invasive blood pressure measurement during surgery is typically conducted on the upper arm, and previous studies about the relationship between intraoperative blood pressure fluctuation and postoperative mortality and morbility have also based on the upper arm measurements. However, in clinical practice, if monitoring blood pressure in the upper arm is not feasible during surgery, the cuff usually be placed on the ankle.
According to a previous study, the systolic blood pressure at the ankle is approximately 17.0 mmHg higher than the systolic blood pressure at the arm in the supine position (95% CI 15.4-21.3 mmHg), while the diastolic blood pressure did not show significant differences in awake state. Since the hemodynamic state of patients under anesthesia differs from that of awake patients, there is insufficient evidence to directly apply the known differences between upper and lower limb blood pressures in awake patients to set target blood pressure ranges during anesthesia. As a result, anesthesiologists often rely on clinical judgment in these situations.
Therefore, this study sets the null hypothesis that 'the differences in blood pressure between the upper and lower limbs before and after anesthesia are the same.' The goal is to determine whether the previously known relationship between upper and lower limb blood pressures in awake patients can be applied to patients under general anesthesia. Additionally, this study aims to investigate the relationship between upper and lower limb blood pressures when the lower limb blood pressure is outside the normal range during general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group T | – | Device: Non-invasive Blood Pressure MeasurementThyroid surgery patients under general anesthesia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving elective thyroid surgery under general anesthesia
Key inclusion criteria (4 listed)
- Patients having elective thyroid surgery under general anesthesia
- Aged between 20 to 80 years old
- American Society of Anesthesiologist(ASA) Physical Status Class I or II
- Individuals who have voluntarily given written consent to participate in this clinical study
Key exclusion criteria (6 listed)
- Patients with Diabetes Mellitus or Peripheral vascular disease
- Patients with a history of Heart disease; Myocardial infarction, Heart failure, etc.
- Patients with Arrhythmia
- Patients with musculoskeletal abnormalities
- Patients for whom the placement of a non-invasive blood pressure cuff is contraindicated: inflammatory diseases or wounds causing pain at the cuff site, severe edema, thrombophlebitis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Blood Pressure MeasurementNon-invasive Blood Pressure Measurement in Both Upper and Lower Limbs | Device | Group T |
Primary outcome
d_MBP(awake)
Time frame: Simultaneously measured values in operating room before anesthesia induction
Difference between upper and lower extremities mean blood pressure in awake state
d_MBP(GA)
Time frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
Difference between upper and lower extremities mean blood pressure during general anesthesia
4 secondary outcomes
d_SBP(awake)
Time frame: Simultaneously measured values in operating room before anesthesia induction
d_SBP(GA)
Time frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
d_DBP(awake)
Time frame: Simultaneously measured values in operating room before anesthesia induction
d_DBP(GA)
Time frame: Simultaneously measured values during general anesthesia in a stable state without significant stimulation
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 30 Mar 2026.
- Background: PubMed 34916049Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
- Results publication: PubMed 30817444Sheppard JP, Albasri A, Franssen M, Fletcher B, Pealing L, Roberts N, Obeid A, Pucci M, McManus RJ, Martin U; British and Irish Hypertension Society. Defining the relationship between arm and leg blood pressure readings: a systematic review and meta-analysis. J Hypertens. 2019 Apr;37(4):660-670. doi: 10.1097/HJH.0000000000001958.
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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.
JOOHYUN LEE principal investigator
Department of Anesthesia and Pain medicine, Ilsan Cha hospital
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 Blood Pressure and Diseases of the Thyroid Gland, run by Ilsan Cha hospital at 1 site in South Korea.
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 4 inclusion and 6 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 30 Mar 2026. 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 South Korea. 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?
d_MBP(awake) (time frame: Simultaneously measured values in operating room before anesthesia induction). 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 NCT06590064, 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 30 Mar 2026.