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

The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness

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

Study Overview

• Status: Completed
• Conditions: Thyroidectomy; Sore Throat; Voice Hoarseness
• Intervention / Treatment: Device: Oral/Nasal Endotracheal Tube, Reinforced (Covidien); Device: TaperGuard oral tracheal tube (Covidien)

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of, 505-757
    • Chonnam National University Hospital
  • Jeollanamdo
    • Hwasun, Jeollanamdo, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hopspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reinforced tube group; use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy	Device: Oral/Nasal Endotracheal Tube, Reinforced (Covidien); Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation
Active Comparator: Conventional tube group; use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy	Device: TaperGuard oral tracheal tube (Covidien); Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hoarseness	compare the incidence and degree of the hoarseness after thyroidectomy	assess after 1hours after operation
sore throat	compare the incidence and degree of the sore throat after thyroidectomy	assess after 1hours after operation
hoarseness	compare the incidence and degree of the hoarseness after thyroidectomy	assess after 24 hours after operation
sore throat	compare the incidence and degree of the sore throat after thyroidectomy	assess after 24hours after operation
hoarseness	compare the incidence and degree of the hoarseness after thyroidectomy	assess after 48 hours after operation
sore throat	compare the incidence and degree of the sore throat after thyroidectomy	assess after 48 hours after operation

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Seongtae Jeong, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Thyroidectomy; Sore Throat; Hoarseness
• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Pharyngitis; Dysphonia; Hoarseness
• Other Study ID Numbers: CNUHH-2017-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No