search
Back to results

Heated Circuit on Sore Throat

Primary Purpose

General Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heated circuit on
Heated circuit off
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anesthesia focused on measuring pharyngitis, intubation, heat

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Difficult airway
  • Mallampatti scores greater than 2
  • Recent sore throat
  • Cervical spine disease
  • Recent upper respiratory infection
  • Recent analgesics
  • History of head and neck surgery
  • Friable teeth
  • Multiple intubation attempts

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Heat

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of participants with postoperative sore throat for postoperative 24 hour

    Secondary Outcome Measures

    Number of participants with postoperative sore throat
    Number of participants with postoperative hoarseness
    Wound pain scores
    Visual analogue scales will be used (10: most imaginable pain, 0: no pain).

    Full Information

    First Posted
    October 1, 2018
    Last Updated
    October 1, 2018
    Sponsor
    Keimyung University Dongsan Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03693417
    Brief Title
    Heated Circuit on Sore Throat
    Official Title
    Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    November 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Keimyung University Dongsan Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing endotracheal intubation for general anesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    General Anesthesia
    Keywords
    pharyngitis, intubation, heat

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Title
    Heat
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Heated circuit on
    Intervention Description
    Heated circuit will be turned on.
    Intervention Type
    Device
    Intervention Name(s)
    Heated circuit off
    Intervention Description
    Heated circuit will be turned off.
    Primary Outcome Measure Information:
    Title
    Number of participants with postoperative sore throat for postoperative 24 hour
    Time Frame
    At 24 hour
    Secondary Outcome Measure Information:
    Title
    Number of participants with postoperative sore throat
    Time Frame
    At 2, 4, and 24 hour
    Title
    Number of participants with postoperative hoarseness
    Time Frame
    At 2, 4, and 24 hour
    Title
    Wound pain scores
    Description
    Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
    Time Frame
    At 2, 4, and 24 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA I-III Patients scheduled for general anesthesia with endotracheal intubation Exclusion Criteria: Difficult airway Mallampatti scores greater than 2 Recent sore throat Cervical spine disease Recent upper respiratory infection Recent analgesics History of head and neck surgery Friable teeth Multiple intubation attempts
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyun-Chang Kim
    Phone
    +821028862876
    Email
    onidori1979@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Heated Circuit on Sore Throat

    We'll reach out to this number within 24 hrs