Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion

September 27, 2018 updated by: Hyun-Chang Kim, Keimyung University Dongsan Medical Center

Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion

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 double-lumen endotracheal intubation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Non-US/Canada
      • Daegu, Non-US/Canada, Korea, Republic of, 137-040
        • Hyun-Chang Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-III
  • Patients scheduled for double-lumen 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Heated breathing circuit will be turned off.
Device: Heated breathing circuit off
Heated breathing circuit will be turned off.
Experimental: Heat
Heated breathing circuit will be turned on.
Device: Heated breathing circuit on
Heated breathing circuit will be turned on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with postoperative sore throat for postoperative 24 h
Time Frame: At 24 hours
At 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative sore throat
Time Frame: At 1, 6, and 24 hours
At 1, 6, and 24 hours
Postoperative sore throat scores
Time Frame: At 1, 6, and 24 hours
At 1, 6, and 24 hours
Number of participants with postoperative hoarseness
Time Frame: At 1, 6, and 24 hours
At 1, 6, and 24 hours
Number of participants with postoperative shivering
Time Frame: At 1, 6, and 24 hours
At 1, 6, and 24 hours
Wound pain scores
Time Frame: At 1, 6, and 24 hours
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
At 1, 6, and 24 hours
Jaw discomfort scores
Time Frame: At 1, 6, and 24 hours
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
At 1, 6, and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heated Circuit POST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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