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NCT03368911 Clinical Trial

The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy

Sore Throat Clinical Trial

Official title:
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03368911
Other study ID # CNUHH-2017-102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date November 30, 2018

Study information
Verified date February 2019
Source Chonnam National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologist physical status 1-3

- Patients undergoing thyroidectomy under general anesthesia

- Tumor size < 2cm

- Patient who do not have any problem in the vocal cord

Exclusion Criteria:

- Patient who is expected difficult intubation (Mallampati class 3 or more)

- Patient who has respiratory disorder

- Previous hoarseness and sore throat history

- Obesity (BMI > 30 kg/m2)

- Recurrent laryngeal injury during operation

- Operation history of oral and laryngeal surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Oral/Nasal Endotracheal Tube, Reinforced (Covidien)
Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation
• TaperGuard oral tracheal tube (Covidien)
Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

Locations
Country Name City State
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Chonnam National University Hwasun Hopspital Hwasun Jeollanamdo

Sponsors (1)
Lead Sponsor Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary hoarseness compare the incidence and degree of the hoarseness after thyroidectomy assess after 1hours after operation
Primary sore throat compare the incidence and degree of the sore throat after thyroidectomy assess after 1hours after operation
Primary hoarseness compare the incidence and degree of the hoarseness after thyroidectomy assess after 24 hours after operation
Primary sore throat compare the incidence and degree of the sore throat after thyroidectomy assess after 24hours after operation
Primary hoarseness compare the incidence and degree of the hoarseness after thyroidectomy assess after 48 hours after operation
Primary sore throat compare the incidence and degree of the sore throat after thyroidectomy assess after 48 hours after operation
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