- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06967896
- Original Trial
Different Models of Tracheal Catheters Are Used for Female Thyroid Glands
May 24, 2026 updated by: Anqing Municipal Hospital
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
180
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
- Name: Sun Ling Lu Sun Ling LU, Master's degree
- Phone Number: 15955565806
- Email: 348092640@qq.com
Study Contact Backup
- Name: Xu Si Qi Xu Si Qi, Doctor
- Phone Number: 13865192106
- Email: errtg555@163.com
Study Locations
-
-
Anhui
-
Anqing, Anhui, China, 246003
- Recruiting
- Department of Anqing Hospital Anesthesiology
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Healthy female thyroid surgery patients, ages 18-65 years, did not have serious systemic disease
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at 1 hour, 6 hour, 24 hour and 48 hour after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 25, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
April 19, 2025
First Submitted That Met QC Criteria
May 5, 2025
First Posted (Actual)
May 13, 2025
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 24, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sun LingLU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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