Status Approved
First Submitted Date
2017/07/12
Registered Date
2017/09/22
Last Updated Date
2017/08/28
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002476 |
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Unique Protocol ID | 4-2016-1041 |
Public/Brief Title | A novel electromagnatic ultrasound-guided arterial line cannulation comparing with conventional ultrasound-guided technique |
Scientific Title | A novel electromagnatic ultrasound-guided arterial line cannulation comparing with conventional ultrasound-guided technique |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 4-2016-1041 |
Approval Date | 2017-01-19 |
Institutional Review Board Name | Yonsei University Health System, Severance Hospital, Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | hyo jin byon |
Title | assist professor |
Telephone | +82-2-2228-2429 |
Affiliation | Yonsei University |
Address | Seoul Yonsei-ro 50-1 Seodaemun-gu |
Contact Person for Public Queries | |
Name | hyo jin byon |
Title | assist professor |
Telephone | +82-2-2228-2429 |
Affiliation | Yonsei University |
Address | Seoul Yonsei-ro 50-1 Seodaemun-gu |
Contact Person for Updating Information | |
Name | hyo jin byon |
Title | assist professor |
Telephone | +82-2-2228-2429 |
Affiliation | Yonsei University |
Address | Seoul Yonsei-ro 50-1 Seodaemun-gu |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-04-03 Actual | |
Target Number of Participant | 76 | |
Primary Completion Date | 2017-12-29 , Anticipated | |
Study Completion Date | 2018-01-18 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-04-03 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
Project ID | 4-2016-1041 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Intraarterial insufflation is an important procedure commonly practiced by patients who are undergoing intensive care or surgeries that require constant blood pressure monitoring. It is inserted into the radial artery, which can be accessed at various locations but is usually easy and less complicated. But the procedure is difficult in itself because only around 2mm in diameter vessels in the average adult. Therefore, ultrasound - guided insertion of the ductus arteriosus can be considered as a method to overcome these difficulties, to increase the initial success rate, to shorten the procedure time, and to reduce complications such as hematoma. However, this also affects the success rate of the procedure and the incidence of complications because the trainer of the operator and the resolution of the ultrasound do not track the path of the needle into the ultrasound screen when the needle is actually punctured. In recent years, ultrasound has been introduced in the clinical field to guide the insertion needle in real time during the procedure such as central venous catheterization or peripheral nerve block using the electromagnetic. This new device, called eZonoTM 4000 (eZono AG, Jena, Germany), shows the relative position and orientation of the ultrasonic probe and needle, the expected trajectory at the time of needle insertion and where the tip of the needle should be positioned on the cross section of the ultrasonic screen. It is reported that the complication rate can be reduced or decreased, and the novice can easily increase the success rate. We compared the success rate and complication rate of arterial line cannula with radial artery cannula using conventional ultrasonography. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | If it is decided to participate in this study, it is divided into a control group and an eZono group through a computerized random assignment. All patients should be fully informed about the purpose and method of the study before the operation, and the research should be conducted in writing. Once the patient arrives at the exenteration room, confirm again that they have agreed to the study. After induction of general anesthesia, the patient is placed in the supine position, and allen test is performed to confirm that the peripheral arterial circulation of the hand is preserved, and then the radial artery that is punctured is sterilized with alcohol cotton. The size of the ductus arteriosum used in the procedure is 20g. The eZono 4000 (eZono AG, Jena, Germany) probe was used to "turn on" the electric field induction function and to insert the patent ductus in the eZono group. To 'turn off' and let it be punished. The ultrasound is placed parallel to the arterial axis and advanced by inserting a needle in an out-of-plane approach to the ultrasound. At this time, the time from the puncture of the skin to the point at which blood starts to come out from the needle by the arterial pressure is measured (T1). When the blood is aspirated, it is defined as the success of insertion of the ductal artery, and the time from the first needle through the needle to the time when the blood is aspirated is measured (T2). In addition, record the total number of punctures, success rate of blood aspiration, incidence of complications, and the number of 20g needle use. The procedure should be performed by a professional who has successfully passed the A-line at least 50 times using ultrasound |
Number of Arms | 2 |
Arm 1 |
Arm Label eZono group |
Target Number of Participant 38 |
|
Arm Type Experimental |
|
Arm Description 'Turn on' the electromagnetism induction function of the eZonoTM 4000 and insert the ductus. |
|
Arm 2 |
Arm Label Groups not using e-zono |
Target Number of Participant 38 |
|
Arm Type Sham comparator |
|
Arm Description Turn off the electric field induction function of eZonoTM 4000 and insert the ductal tube. |
9. Subject Eligibility
Condition(s)/Problem(s) | Not Applicable-Etc |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description Adult patients over 19 years of age who are required to have a A-line insertion |
|
Exclusion Criteria |
- Vascular malformations - hemodynamically unstable patient - Blood coagulation disorder - Patients with Peripheral Arterial Occlusive Disease - reoperation - emergency surgery |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Percentage of success and vascular wall puncture |
|
Timepoint | The time from when the skin is punctured to the point at which blood starts to form on the needle and starts to come out from the arterial pressure, the time from when the blood first comes out through the needle to the time when the blood is sucked |
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Secondary Outcome(s) 1 | ||
Outcome | When anesthesia induces an unexpected side effect (anaphylaxis, difficult airway management, etc.) or other causes, such as severe hemodynamic changes or general condition of the patient is worsened. |
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Timepoint | During anesthesia induction, immediately after induction of anesthesia |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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