Sore ThroatNCT06967896
Different Models of Tracheal Catheters Are Used for Female Thyroid Glands
An observational study of Sore Throat and Tracheal Tubes With an Inner Diameter of 6.0mm, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sore Throat, Tracheal Tubes With an Inner Diameter of 6.0mm, Tracheal Tubes With an Inner Diameter of 6.5mm
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Healthy female thyroid surgery patients, ages 18-65 years, did not have serious systemic disease
Who may be able to join
- Female;
- Thyroid surgery should be performed under general anesthesia (GA) at an appropriate time;
- ASA grade I-III;
- Aged 18-65 years;
- BMI less than 35Kg/m2
- In line with ethics, patients voluntarily accept this experiment and sign informed consent.
Who cannot join
- Reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction
- Upper respiratory tract infection occurred within 2 weeks before surgery
- Unable to insert ET (no more than two intubations)
- Patients with hoarseness or sore throat before surgery
- Language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Anqing Hospital Anesthesiology
Anqing, Anhui, 246003
About this study
Official title: A Randomized Controlled Trial Comparing Different Models of Tracheal Tube for Thyroid Surgery in Women
Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. The participants were randomly assigned into three groups(n=60 each group):Group A: Tracheal catheter group with an inner diameter of 6.0mm, Group B: Tracheal catheter group with an inner diameter of 6.5mm, Group C: Tracheal catheter group with an inner diameter of 7.0mm.The incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.
- Conditions
- Sore Throat, Tracheal Tubes With an Inner Diameter of 6.0mm, Tracheal Tubes With an Inner Diameter of 6.5mm, Tracheal Tubes With an Inner Diameter of 7.0mm
- Keywords
- thyroid surgery, sore throat, Tracheal tube
- Medical subject headings
- Pharyngitis
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 |
|---|---|---|
| 6.0# | Insert the tracheal tube of model 6.0# | |
| 6.5# | Insert the tracheal tube of model 6.5# | |
| 7.0# | Insert the tracheal tube of model 7.0# |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative sore throat
The incidence of postoperative sore throat
Measured: at 1 hour, 6 hour, 24 hour and 48 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967896
- Sponsor's protocol ID
- Sun LingLU
- Status last verified
- May 2026
- First submitted
- 19 Apr 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Different Models of Tracheal Tube for Thyroid Surgery in Women
- ClinicalTrials.gov ID
- NCT06967896
- Acronym / sponsor ID
- Sun LingLU
- Conditions
- Sore Throat, Tracheal Tubes With an Inner Diameter of 6.0mm, Tracheal Tubes With an Inner Diameter of 6.5mm, Tracheal Tubes With an Inner Diameter of 7.0mm
- Keywords
- thyroid surgery, sore throat, Tracheal tube
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 May 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.
Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. The participants were randomly assigned into three groups(n=60 each group):Group A: Tracheal catheter group with an inner diameter of 6.0mm, Group B: Tracheal catheter group with an inner diameter of 6.5mm, Group C: Tracheal catheter group with an inner diameter of 7.0mm.The incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6.0# | – | –Insert the tracheal tube of model 6.0# |
| 6.5# | – | –Insert the tracheal tube of model 6.5# |
| 7.0# | – | –Insert the tracheal tube of model 7.0# |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy female thyroid surgery patients, ages 18-65 years, did not have serious systemic disease
Key inclusion criteria (6 listed)
- Female;
- Thyroid surgery should be performed under general anesthesia (GA) at an appropriate time;
- ASA grade I-III;
- Aged 18-65 years;
- BMI less than 35Kg/m2
Key exclusion criteria (5 listed)
- Reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction
- Upper respiratory tract infection occurred within 2 weeks before surgery
- Unable to insert ET (no more than two intubations)
- Patients with hoarseness or sore throat before surgery
- Language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate
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
The incidence of postoperative sore throat
Time frame: at 1 hour, 6 hour, 24 hour and 48 hour after operation
The incidence of postoperative sore throat
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Sore Throat and Tracheal Tubes With an Inner Diameter of 6.0mm, run by Anqing Municipal Hospital at 1 site in China.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 May 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Ling Lu Sun Ling LU, Master's degree (15955565806, 348092640@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative sore throat (time frame: at 1 hour, 6 hour, 24 hour and 48 hour after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.