Different Models of Tracheal Catheters Are Used for Female Thyroid Glands

NCT06967896 | Recruiting

• 1 other identifier: Sun LingLU
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative sore throat

  The incidence of postoperative sore throat

  at 1 hour, 6 hour, 24 hour and 48 hour after operation

Study Arms (3)

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#

Eligibility Criteria

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

Study Population

Healthy female thyroid surgery patients, ages 18-65 years, did not have serious systemic disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246003, China

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Sun Ling Lu Sun Ling LU, Master's degree

CONTACT

15955565806; 348092640@qq.com

Xu Si Qi Xu Si Qi, Doctor

CONTACT

13865192106; errtg555@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 13, 2025
• Study Start: October 9, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)