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

NCT04393844 | Unknown

• 1 other identifier: 2004-206-1120
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Venous Catheters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of insertion attempts

  during procedure

• Number of additional manipulation

  during procedure

• type of additional manipulation

  during procedure

• the location of catheter in case of the malposition at one time

  confirmation through ultrasound procedure completed

• final success rate

  procedure

Study Arms (2)

with obturator

PLACEBO COMPARATOR

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

without obturator

EXPERIMENTAL

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

Interventions

turbo-ject PICC set OTHER

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.

with obturator; without obturator

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea, 03080, South Korea

Location

Study Officials

• Hee-Soo Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: June 2, 2020
• Primary Completion: April 17, 2022
• Study Completion: July 15, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)