The Success Rate of Catheter Insertion by the Presence of Obturator During Peripherally Inserted Central Venous Catheter

Study Overview
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Brief Summary
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In pediatric patients under the age of 18 who undergo surgery under general anesthesia, when inserting peripherally inserted central venous catheterization, the group that inserts the catheter with the obturator and the group that inserts the catheter without the obturator is inserted into the appropriate position.

Detailed Description
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In pediatric patients under the age of 18 who undergo surgery under general anesthesia, when inserting peripherally inserted central venous catheterization, the group that inserts the catheter with the obturator and the group that inserts the catheter without the obturator is inserted into the appropriate position. There is no study confirming the probability of being placed in the central vein at a time when the catheter is inserted without the obturator, and there is no study comparing the clinical effect by dividing the case with the obturator and the obturator. In children, the blood vessels are small and there is a high probability that they cannot be located in the central vein when the peripheral vein is inserted. Therefore, when a peripheral implanted central venous tube is inserted into a pediatric patient under general anesthesia under 18 years of age, the probability that the catheter is inserted without using an obturator will be located in the central vein at a time rather than using an obturator to insert the catheter. It could help pediatric patients to manage anesthesia and post-surgical care by reducing potential complications from using obturator.

Official Title
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Comparison of Success Rate of Catheter Insertion by the Presence of Obturator During Peripherally Inserted Central Venous Catheter in Pediatric Patient Undergoing General Anesthesia; Prospective Randomized Controlled Study

Conditions
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Central Venous Catheters

Intervention / Treatment
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* Other: turbo-ject PICC set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children under 18 years of age undergoing general anesthesia surgery at Seoul National University Hospital ASA class I, II If the legal guardian voluntarily consents after the explanation of the research Exclusion Criteria: Patients with a history of heart surgery or a history of congenital heart disease Patients with hemodynamically unstable or massive bleeding and shock Infection or systemic infection is suspected Patients who have a blood clotting disorder Abnormal cases when the vessel to be inserted is confirmed by ultrasound the cases that the researcher determines that it is inappropriate

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: with obturator<br>A group using an obturator when performing peripherally inserted central venous catheterization in children under 18 years of age under general anesthesia. | Other: turbo-ject PICC set<br>* The turbo-ject PICC set, which will be used in this study, is the set for peripherally inserted central catheterization. In this study, we will see the difference according to the presence or absence of the hydrophilic coated stiffening obturator included in this turbo-ject PICC set.<br>|
| Experimental: without obturator<br>A group that does not use an obturator when performing peripherally inserted central venous catheterization in children under 18 years of age under general anesthesia. | Other: turbo-ject PICC set<br>* The turbo-ject PICC set, which will be used in this study, is the set for peripherally inserted central catheterization. In this study, we will see the difference according to the presence or absence of the hydrophilic coated stiffening obturator included in this turbo-ject PICC set.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate at one time | Success rate to place into the central vein without additional treatment at one time | confirmation through ultrasound procedure completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insertion attempts | Number of insertion attempts to place into the central vein | during procedure | 
| Number of additional manipulation | Number of additional manipulation to place into the central vein | during procedure | 
| type of additional manipulation | type of additional manipulation to place into the central vein | during procedure | 
| the location of catheter in case of the malposition at one time | the location of catheter in case of the malposition at one time | confirmation through ultrasound procedure completed | 
| final success rate | final success rate based on confirming in postoperative chest x-ray | procedure | 
| final catheter location | final catheter location confirming in postoperative chest X-ray | procedure | 
| other complication | other complication such as hematoma, vessel rupture, nonfunction, kinking of catheter | procedure |