A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
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|ClinicalTrials.gov Identifier: NCT03252197|
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017 Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study||Device: UGIJVC with needle guide device Device: UGIJVC without needle guide device||Not Applicable|
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blinded to study arm, Outcome assessor measured outcome variables based on recorded images.|
|Official Title:||A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device|
|Actual Study Start Date :||March 11, 2017|
|Actual Primary Completion Date :||June 24, 2017|
|Actual Study Completion Date :||June 24, 2017|
Experimental: New device group
participants who are tested performance for ultrasound guided cannulation using device
Device: UGIJVC with needle guide device
Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
Active Comparator: Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method
Device: UGIJVC without needle guide device
participants who are tested performance for ultrasound guided cannulation using conventional method.
Other Name: Conventional group
- First attempt success [ Time Frame: Within 2 minutes or after start to insertion attempt ]The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
- Posterior wall puncture of the internal jugular procedure, comfort level with procedure [ Time Frame: Within 2 minutes or after start to insertion attempt ]It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
- Carotid artery puncture [ Time Frame: Within 2 minutes or after start to insertion attempt ]
It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt.
measurement unit : Yes or no (categorical variable)
- Time to cannulation [ Time Frame: Within 2 minutes or after start to insertion attempt ]It was defined as the time from time out for procedure start to end point measurement unit : second
- Comfort level [ Time Frame: Within 2 minutes or after start to insertion attempt ]It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252197
|Korea, Republic of|
|Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital|
|Seoul, Korea, Republic of, 03722|