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Pediatric airway ultrasound for endotracheal tube selection

Status Approved

First Submitted Date

2020/07/21
Registered Date

2020/07/23
Last Updated Date

2021/02/04

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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	KCT0005251
Unique Protocol ID	KANGDONG 2020-05-001
Public/Brief Title	The purpose of our study is to evaluate the efficacy of airway ultrasound application for decreasing the airway and respiratory complication and adverse events by selection of correct endotracheal tube size and proper insertion depth in the airway management of pediatric patients
Scientific Title	Pediatric airway ultrasound for endotracheal tube selection
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-05-001
Approval Date	2020-05-20
Institutional Review Board Name	The Institutional Review Board of the Kang-Dong Sacred Heart Hospital
Institutional Review Board Address	150, Seongan-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-2224-2172
Data Monitoring Committee	No

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	IL SEOK KIM
Title	Associate Professor
Telephone	+82-2-2225-2858
Affiliation	Kangdong Sacred Heart Hospital
Address	150 Sungan-ro, Gangdong-gu, Seoul 134-701, Republic of Korea
Contact Person for Public Queries
Name	IL SEOK KIM
Title	Associate Professor
Telephone	+82-2-2225-2858
Affiliation	Kangdong Sacred Heart Hospital
Address	150 Sungan-ro, Gangdong-gu, Seoul 134-701, Republic of Korea
Contact Person for Updating Information
Name	IL SEOK KIM
Title	Associate Professor
Telephone	+82-2-2225-2858
Affiliation	Kangdong Sacred Heart Hospital
Address	150 Sungan-ro, Gangdong-gu, Seoul 134-701, Republic of Korea

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	Completed
Date of First Enrollment	2020-05-20 Actual
Target Number of Participant	51
Primary Completion Date	2021-02-04 , Actual
Study Completion Date	2021-02-04 , Actual
Name of Study	Kangdong Sacred Heart Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-05-20 ,

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	National Research Foundation
Organization Type	Government
Project ID	2018R1D1A1B07043429

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hallym University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Anesthesia for cleft repair surgery carries an increased risk of airway and respiratory morbidity that was attributed to airway obstruction, difficulty in intubation and endotracheal tube related problems. The purpose of our study was to evaluate the efficacy of airway ultrasound application for decreasing the airway and respiratory complication and adverse events by selection of correct endotracheal tube size and proper insertion depth in the airway management of pediatric patients undergoing cleft repair surgery.

Study Summary Information

Lay Summary

Anesthesia for cleft repair surgery carries an increased risk of airway and respiratory morbidity that was attributed to airway obstruction, difficulty in intubation and endotracheal tube related problems. The purpose of our study was to evaluate the efficacy of airway ultrasound application for decreasing the airway and respiratory complication and adverse events by selection of correct endotracheal tube size and proper insertion depth in the airway management of pediatric patients undergoing cleft repair surgery.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	51
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Conventional group
Cohort/ Group 1	Cohort/Group Description Size of endotracheal tube is selected by the age-based formula and insertion depth is determined by auscultation
Cohort/ Group 2	Cohort/Group Label Ultrasound group
Cohort/ Group 2	Cohort/Group Description Size of endotracheal tube is selected using ultrasound measurement of subglottic diameter and insertion depth is determined by auscultation and lung ultrasound
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Pediatric patients performed primary repair of cleft lip and palate under general anesthesia at the Kang-Dong Sacred Heart Hospital in Republic of Korea.
Sampling Method	Pediatric patients were undergone cleft repair surgery from March 2016 to january 2019 and were consecutively divided into 2 groups either the age-based method (conventional group) or the ultrasound method (ultrasound group) for selection of ET tube size and verifying ET tube position according to use of ultrasound in the airway management.
Condition(s)/Problem(s)	* (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities (Q37.1)Cleft hard palate with unilateral cleft lip cleft palate, cleft lip
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 2Month~28Month
	Description Pediatric patients with cleft lip and cleft palate need to cleft repair surgery
Exclusion Criteria	Pediatric patients with hemodynamic unstability
Healthy Volunteers	No

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	Efficacy
Outcome	the incidence of airway and respiratory complication and adverse events occurred in intraoperative and immediate postoperative periods.
Timepoint	Intraoperative and immediate postoperative periods
Secondary Outcome(s) 1
Outcome	size of endotracheal tube, insertion depth
Timepoint	Induction of anesthesia

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	No

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