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Determining the ideal insertion depth of ultrasound guided right subclavian vein catheter in pediatric patients by anatomic landmarks

Status Approved

First Submitted Date

2020/06/02
Registered Date

2020/06/03
Last Updated Date

2021/09/22

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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	KCT0005082
Unique Protocol ID	CNUH 2020-04-125
Public/Brief Title	What factors determine the appropriate insertion depth when inserting a central vein in pediatric patients
Scientific Title	Determining the ideal insertion depth of ultrasound guided right subclavian vein catheter in pediatric patients by anatomic landmarks
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	CNUH 2020-04-125
Approval Date	2020-05-07
Institutional Review Board Name	Chungnam national university hospital institutional review board
Institutional Review Board Address	266, Munhwa-ro, Jung-gu, Daejeon
Institutional Review Board Telephone	042-280-6714
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	Boohwi Hong
Title	Assistant prof.
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	Chungnam National University Hospital, 282 munhwa ro junggu daejeon
Contact Person for Public Queries
Name	Boohwi Hong
Title	Assistant prof.
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	Chungnam National University Hospital, 282 munhwa ro junggu daejeon
Contact Person for Updating Information
Name	Boohwi Hong
Title	Assistant prof.
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	Chungnam National University Hospital, 282 munhwa ro junggu daejeon

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	Recruiting
Date of First Enrollment	2020-05-07 Actual
Target Number of Participant	100
Primary Completion Date	2020-06-01 , Actual
Study Completion Date	2020-06-01 , Actual
Name of Study	Chungnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-05-07 ,

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	Chungnam National University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Unlike adults, it is very difficult to determine the length of the catheter when a central vein is inserted in a pediatric patient. The proper location of the central vein tip is the boundary between the relative vein and the right atrium, which is highly correlated with the first branch of the organ on chest radiography. Recently, the use of ultrasound has several advantages, such as increasing the success rate of central venous tube insertion in children and preventing complications such as pneumothorax. We would like to implement a model that predicts the ideal catheter insertion length using surface anatomical locations when inserting a central vein using ultrasound. Inadequate central vein and insertion length can lead to errors in central vein pressure measurement, and drug injection may be subcutaneous or even right atrium rupture. Therefore, it is very important to place the tip of the central vein in the superior vena cava.

Study Summary Information

Lay Summary

Unlike adults, it is very difficult to determine the length of the catheter when a central vein is inserted in a pediatric patient. The proper location of the central vein tip is the boundary between the relative vein and the right atrium, which is highly correlated with the first branch of the organ on chest radiography. Recently, the use of ultrasound has several advantages, such as increasing the success rate of central venous tube insertion in children and preventing complications such as pneumothorax. We would like to implement a model that predicts the ideal catheter insertion length using surface anatomical locations when inserting a central vein using ultrasound. Inadequate central vein and insertion length can lead to errors in central vein pressure measurement, and drug injection may be subcutaneous or even right atrium rupture. Therefore, it is very important to place the tip of the central vein in the superior vena cava.

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	100
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label pediatric catheterization
Cohort/ Group 1	Cohort/Group Description Check the following. 1. The location of the catheter tip and the distance of the trachea bifurcation 2. Distance from the needle insertion point to the right clavicle end 3. Dstance between the right clavicular head and midpoint of the perpendicular line drawn from sternal head of the right clavicle to the line connecting both nipples 4. The actual insertion length of the catheter 5. Patient's weight, age (months), height Create a prediction model for the insertion depth by landmarks.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Pediatric patients visiting Chungnam National University Hospital
Sampling Method	Among children who visit Chungnam National University Hospital, patients with central vein catheter insertion for ICU admission or majorsurgery, non random recruit
Condition(s)/Problem(s)	* (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities (Q24.9)Congenital malformation of heart, unspecified Heart Defects, Congenital
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 0Month~2Month
	Description Pediatric patients aged 0-24 months Since 2016, pediatric patients who have a central vein catheter insertion for consultation or major surgery
Exclusion Criteria	Except for non-right subclavian vein insertion
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	Not applicable
Outcome	vertical distance between the cathter tip and carina on chest AP image taken after the catheterization
Timepoint	retrospectively review the image taken immediately after the procedure
Secondary Outcome(s) 1
Outcome	distance between the insertion point of catheter (I) and the right clavicular head(A)
Timepoint	during procedure
Secondary Outcome(s) 2
Outcome	distance between the right clavicular head and midpoint (B) of the perpendicular line drawn from sternal head of the right clavicle to the line connecting both nipples(A)
Timepoint	during procedure

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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