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

NCT ID: NCT04393844

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2023-07-15

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.

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.

Conditions

Central Venous Catheters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

with obturator

A group using an obturator when performing peripherally inserted central venous catheterization in children under 18 years of age under general anesthesia.

Group Type: PLACEBO_COMPARATOR

turbo-ject PICC set

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

turbo-ject PICC set

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Soo Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee-Soo Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea, South Korea

Countries

South Korea

Other Identifiers

2004-206-1120

Identifier Type: -

Identifier Source: org_study_id