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The study plan is cancelled because of difficulties in the progress of the study.
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The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in cardiac surgical patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device group (Group D) | Experimental | Arm Description: Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound and simple needle guide device. |
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| sono only group (Group S) | Placebo Comparator | Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sono with Device | Device | 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, both the device and sono-guided internal jugular vein catheterization was performed. |
| Measure | Description | Time Frame |
|---|---|---|
| First access success rate | First access success rate was defined as the number of sono-guided catheterization obtained within first attempt. | up to 5 minutes after insertion of puncture needle |
| Measure | Description | Time Frame |
|---|---|---|
| insertion time | defined as the time in seconds between the beginning of the procedure and guide-wire insertion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul | Korea | 03722 | South Korea |
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participants, investicator, outcome assessors will be blinded for group allocation.
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| sono only | Device | In Group S, simple needle guide device was not attached to the sono probe. After induction of anesthesia, only sono-guided internal jugular vein catheterization was performed. |
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| 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) | 10 minutes after the beginning of the procedure |
| The number of attempts | The number of attempts was counted each time a subject inserted a guide needle into the neck surface, followed by withdrawal, redirection, or reinsertion. | 10 minutes after the beginning of the procedure |