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

Central Venous Catheters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04393844
• Other study ID #: 2004-206-1120
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: July 15, 2023

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: July 15, 2023
• Est. primary completion date: April 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheters

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul, South Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of insertion attempts	Number of insertion attempts to place into the central vein	during procedure
Secondary	Number of additional manipulation	Number of additional manipulation to place into the central vein	during procedure
Secondary	type of additional manipulation	type of additional manipulation to place into the central vein	during procedure
Secondary	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
Secondary	final success rate	final success rate based on confirming in postoperative chest x-ray	procedure
Secondary	final catheter location	final catheter location confirming in postoperative chest X-ray	procedure
Secondary	other complication	other complication such as hematoma, vessel rupture, nonfunction, kinking of catheter	procedure