Clinical trial NCT04393844: The Success Rate of Catheter Insertion by the Presence of Obturator During Peripherally Inserted Central Venous Catheter
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Venous Catheters
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 65
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Success rate at one time
timeFrame: confirmation through ultrasound procedure completed
Secondary outcomes:
measure: Number of insertion attempts
timeFrame: during procedure
measure: Number of additional manipulation
timeFrame: during procedure
measure: type of additional manipulation
timeFrame: during procedure
measure: the location of catheter in case of the malposition at one time
timeFrame: confirmation through ultrasound procedure completed
measure: final success rate
timeFrame: procedure
measure: final catheter location
timeFrame: procedure
measure: other complication
timeFrame: procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul, South Korea
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: