Central Venous CathetersNCT04393844
The Success Rate of Catheter Insertion by the Presence of Obturator During Peripherally Inserted Central Venous Catheter
A study testing turbo-ject PICC set in people with Central Venous Catheters, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheters
- What is being tested?
- turbo-ject PICC set
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2020to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
About this study
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
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.
Read the 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
- Being tested
- turbo-ject PICC set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turbo-ject PICC setOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: turbo-ject PICC set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at one time
Success rate to place into the central vein without additional treatment at one time
Measured: confirmation through ultrasound procedure completed
Secondary outcomes (7)
Number of insertion attempts
Number of insertion attempts to place into the central vein
Measured: during procedure
Number of additional manipulation
Number of additional manipulation to place into the central vein
Measured: during procedure
type of additional manipulation
type of additional manipulation to place into the central vein
Measured: during procedure
the location of catheter in case of the malposition at one time
the location of catheter in case of the malposition at one time
Measured: confirmation through ultrasound procedure completed
final success rate
final success rate based on confirming in postoperative chest x-ray
Measured: procedure
final catheter location
final catheter location confirming in postoperative chest X-ray
Measured: procedure
other complication
other complication such as hematoma, vessel rupture, nonfunction, kinking of catheter
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start2 Jun 2020
- Primary completion17 Apr 2022
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393844
- Sponsor's protocol ID
- 2004-206-1120
- Status last verified
- Feb 2023
- First submitted
- 14 May 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04393844
- Acronym / sponsor ID
- 2004-206-1120
- Conditions
- Central Venous Catheters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with obturator | Placebo comparator | Other: turbo-ject PICC setA group using an obturator when performing peripherally inserted central venous catheterization in children under 18 years of age under general anesthesia. |
| without obturator | Experimental | Other: turbo-ject PICC setA group that does not use an obturator when performing peripherally inserted central venous catheterization in children under 18 years of age under general anesthesia. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| turbo-ject PICC setThe 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. | Other | with obturator, without obturator |
Primary outcome
Success rate at one time
Time frame: confirmation through ultrasound procedure completed
Success rate to place into the central vein without additional treatment at one time
7 secondary outcomes
Number of insertion attempts
Time frame: during procedure
Number of additional manipulation
Time frame: during procedure
type of additional manipulation
Time frame: during procedure
the location of catheter in case of the malposition at one time
Time frame: confirmation through ultrasound procedure completed
final success rate
Time frame: procedure
final catheter location
Time frame: procedure
other complication
Time frame: procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing turbo-ject PICC set in people with Central Venous Catheters, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate at one time (time frame: confirmation through ultrasound procedure completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.