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The effects of direction of the bevel of endotracheal tubes on the practice and postoperative sore throat when performing fibreoptic‐guided tracheal intubation

Status Approved

First Submitted Date

2020/12/04
Registered Date

2020/12/15
Last Updated Date

2021/12/31

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005677
Unique Protocol ID	KNUH 2020-10-025
Public/Brief Title	The effects of direction of the bevel of endotracheal tubes on the practice and postoperative sore throat when performing fibreoptic‐guided tracheal intubation
Scientific Title	The effects of direction of the bevel of endotracheal tubes on the practice and postoperative sore throat when performing fibreoptic‐guided tracheal intubation
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KNUH 2020-10-025
Approval Date	2020-12-03
Institutional Review Board Name	Kyungpook National University Hospital Institutional Review Board
Institutional Review Board Address	130, Dongdeok-ro, Jung-gu, Daegu
Institutional Review Board Telephone	053-200-5430
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hyunjee Kim
Title	Professor
Telephone	+82-53-420-5863
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu
Contact Person for Public Queries
Name	Hyunjee Kim
Title	Professor
Telephone	+82-53-420-5863
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu
Contact Person for Updating Information
Name	Hyunjee Kim
Title	Professor
Telephone	+82-53-420-5863
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2021-01-04 Actual
Target Number of Participant	86
Primary Completion Date
Study Completion Date
Name of Study	Kyungpook National University Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2021-01-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyungpook National University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to minimize trauma around the larynx and glottis that occur in the process of placing an endotracheal tube and to perform more rapid endotracheal intubation when performing fibreoptic‐guided tracheal intubation. The effect of the bevel direction of the tube when the endotracheal tube is pushed through the bronchoscope is investigated. Endotracheal intubation is performed by dividing the subject into a control group with a tube bevel to the left and an experimental group with a tube bevel to the backward. The bronchoscopy operator grades according to the degree of resistance at the time of entry into the tube and records it on the case record sheet. At the end of the surgery, the area around the glottis is examined to evaluate the trauma. After surgery, the severity of sore throat and hoarseness is checked and recorded.

Study Summary Information

Lay Summary

The purpose of this study is to minimize trauma around the larynx and glottis that occur in the process of placing an endotracheal tube and to perform more rapid endotracheal intubation when performing fibreoptic‐guided tracheal intubation. The effect of the bevel direction of the tube when the endotracheal tube is pushed through the bronchoscope is investigated. 
Endotracheal intubation is performed by dividing the subject into a control group with a tube bevel to the left and an experimental group with a tube bevel to the backward. 
The bronchoscopy operator grades according to the degree of resistance at the time of entry into the tube and records it on the case record sheet. At the end of the surgery, the area around the glottis is examined to evaluate the trauma. After surgery, the severity of sore throat and hoarseness is checked and recorded.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Factorial
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	When an endotracheal tube is inserted, the group is divided into a group in which the direction of the bevel of the tube is directed to the left and the group whose direction of the bevel is toward the rear.
Number of Arms	2
Arm 1	Arm Label group L
	Target Number of Participant 43
	Arm Type Active comparator
	Arm Description During endotracheal intubation, the direction of the bevel of the tube is to the left.
Arm 2	Arm Label group B
	Target Number of Participant 43
	Arm Type Experimental
	Arm Description During endotracheal intubation, the bevel of the tube faces backward.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J98.9)Respiratory disorder, unspecified airway injury
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 18Year~65Year
	Description • ASA (American Society of Anesthesiologists) physical status classification system 1 ~ 2 • Expected operation time within 3 hours • Patient-controlled-analgesia is not planned • Laparoscopic cholecystectomy, gastric and small intestine surgery, laparoscopic gynecological surgery, breast surgery
Exclusion Criteria	• Predictive factors for difficult airway intubation: Mallampati class III or IV, Thyromental distance <6.5 cm, body mass index> 30 kg/m2, • Pregnant • Recent history of upper respiratory infections or sore throats • Current steroid administration.
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	sore throat
Timepoint	after the surgery
Secondary Outcome(s) 1
Outcome	hoarseness
Timepoint	after the surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2023. 12
Way of Sharing	Available on Request (dittojee@naver.com)

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