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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Venous Catheters
• Intervention / Treatment: Other: turbo-ject PICC set

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung-Ae Cho, MD; Phone Number: +821071830073; Email: whtjddo89@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, South Korea
    • Seoul, Seoul, South Korea, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: with obturator; 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; 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.
EXPERIMENTAL: without obturator; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2020
• Primary Completion (ACTUAL): April 17, 2022
• Study Completion (ANTICIPATED): July 15, 2023

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (ACTUAL): May 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2004-206-1120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No