Patients Undergoing SurgeryNCT03595137
The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial
A study testing Sono with Device and Sono only in people with Patients Undergoing Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients Undergoing Surgery
- What is being tested?
- Sono with Device and Sono only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2018to 31 Dec 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult ( ≧19 years old)
- patients undergoing elective surgery
Who cannot join
- emergency surgery
- patients under cervical immobilization
- anatomical abnormality for Right internal jugular vein catheterization
- infection or hematoma at puncture site
- patients who did not need internal jugular vein catheterization
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
Jin Ha Park, MD, 82-2-2228-2420, realsummer@yuhs.ac
About this study
The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients
- Conditions
- Patients Undergoing Surgery
- Being tested
- Sono with Device, Sono only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono with DeviceDevice
In Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
Sono onlyDevice
In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| sono with simple needle guide device group (Group D) | Experimental | sono with simple needle guide device Simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed. Receives: Device: Sono with Device |
| sono only group (Group S) | Placebo comparator | sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed. Receives: Device: Sono only |
What is being measured
The primary outcome is the main question the study is designed to answer.
First access success rate
First access success rate was defined as the number of sono-guided catheterization obtained within first attempt
Measured: up to 5 minutes after insertion of puncture needle
Secondary outcomes (4)
insertion time
defined as the time in seconds between the beginning of the procedure and guide-wire insertion
Measured: 10 minutes after the beginning of the procedure
complication rate
incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein
Measured: 24 hours after surgery
ease of procedure
In order to measure the degree of difficulty felt by the subjects during the procedure, a 100mm visual analogue scale was used to measure 10 difficulty levels (100mm; ease, 0mm ; difficult)
Measured: 10 minutes after the beginning of the procedure
the number of separate skin puncture
Measured: 10 minutes after the beginning of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start13 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. sono with simple needle guide device group 2. sono only group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595137
- Sponsor's protocol ID
- 1-2018-0027
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- 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 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03595137
- Acronym / sponsor ID
- 1-2018-0027
- Conditions
- Patients Undergoing Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Jul 2018 (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.
The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. sono with simple needle guide device group 2. sono only group
| Arm | Type | Receives |
|---|---|---|
| sono with simple needle guide device group (Group D) | Experimental | Device: Sono with Devicesono with simple needle guide device Simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed. |
| sono only group (Group S) | Placebo comparator | Device: Sono onlysono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult ( ≧19 years old)
- patients undergoing elective surgery
Key exclusion criteria (5 listed)
- emergency surgery
- patients under cervical immobilization
- anatomical abnormality for Right internal jugular vein catheterization
- infection or hematoma at puncture site
- patients who did not need internal jugular vein catheterization
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 |
|---|---|---|
| Sono with DeviceIn Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed. | Device | sono with simple needle guide device group (Group D) |
| Sono onlyIn group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia | Device | sono only group (Group S) |
Primary outcome
First access success rate
Time frame: up to 5 minutes after insertion of puncture needle
First access success rate was defined as the number of sono-guided catheterization obtained within first attempt
4 secondary outcomes
insertion time
Time frame: 10 minutes after the beginning of the procedure
complication rate
Time frame: 24 hours after surgery
ease of procedure
Time frame: 10 minutes after the beginning of the procedure
the number of separate skin puncture
Time frame: 10 minutes after the beginning of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sono with Device and Sono only in people with Patients Undergoing Surgery, run by Yonsei University 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 2 inclusion and 5 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 23 Jul 2018. 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?
Contact Jin Ha Park Park, MD (82-2-2228-2420, realsummer@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First access success rate (time frame: up to 5 minutes after insertion of puncture needle). 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 23 Jul 2018.