Heated Circuit on Sore Throat

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Hyun-Chang Kim，Keimyung University Dongsan Medical Center

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participants with postoperative sore throat for postoperative 24 hour[ Time Frame: At 24 hour ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Number of participants with postoperative sore throat[ Time Frame: At 2, 4, and 24 hour ]
Number of participants with postoperative hoarseness[ Time Frame: At 2, 4, and 24 hour ]
Wound pain scores[ Time Frame: At 2, 4, and 24 hour ]
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).

Descriptive Information

Brief Title ^ICMJE

Heated Circuit on Sore Throat

Official Title ^ICMJE

Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Device: Heated circuit on
Heated circuit will be turned on.
Device: Heated circuit off
Heated circuit will be turned off.

Study Arms

Active Comparator: Control
Experimental: Heat

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2019

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Hyun-Chang Kim，Keimyung University Dongsan Medical Center

Study Sponsor ^ICMJE

Keimyung University Dongsan Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Keimyung University Dongsan Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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