Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393844
Enrollment
65
Registered
2020-05-19
Start date
2020-06-02
Completion date
2023-07-15
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheters

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.

Interventions

OTHERturbo-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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate at one timeconfirmation through ultrasound procedure completedSuccess rate to place into the central vein without additional treatment at one time

Secondary

MeasureTime frameDescription
Number of additional manipulationduring procedureNumber of additional manipulation to place into the central vein
type of additional manipulationduring proceduretype of additional manipulation to place into the central vein
the location of catheter in case of the malposition at one timeconfirmation through ultrasound procedure completedthe location of catheter in case of the malposition at one time
Number of insertion attemptsduring procedureNumber of insertion attempts to place into the central vein
final catheter locationprocedurefinal catheter location confirming in postoperative chest X-ray
other complicationprocedureother complication such as hematoma, vessel rupture, nonfunction, kinking of catheter
final success rateprocedurefinal success rate based on confirming in postoperative chest x-ray

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026