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

Overview

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

Full Title of Study: “The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2018

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Reinforced tube group
    • use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy
  • Active Comparator: Conventional tube group
    • use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy

Clinical Trial Outcome Measures

Primary Measures

  • hoarseness
    • Time Frame: assess after 1hours after operation
    • compare the incidence and degree of the hoarseness after thyroidectomy
  • sore throat
    • Time Frame: assess after 1hours after operation
    • compare the incidence and degree of the sore throat after thyroidectomy
  • hoarseness
    • Time Frame: assess after 24 hours after operation
    • compare the incidence and degree of the hoarseness after thyroidectomy
  • sore throat
    • Time Frame: assess after 24hours after operation
    • compare the incidence and degree of the sore throat after thyroidectomy
  • hoarseness
    • Time Frame: assess after 48 hours after operation
    • compare the incidence and degree of the hoarseness after thyroidectomy
  • sore throat
    • Time Frame: assess after 48 hours after operation
    • compare the incidence and degree of the sore throat after thyroidectomy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chonnam National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Seongtae Jeong, Associate Professor – Chonnam National University Hospital
  • Overall Official(s)
    • Seongtae Jeong, Principal Investigator, Chonnam National University Hospital

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