Cardiac Surgery
Conditions
Brief summary
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
Interventions
DEVICESono with 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.
DEVICEsono only
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
participants, investicator, outcome assessors will be blinded for group allocation.
Intervention model description
1. sono with simple needle guide device group 2. sono only group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. adult ( ≧19 years old) 2. patients undergoing elective cardiac surgery
Exclusion criteria
1. emergency surgery 2. patients under cervical immobilization 3. anatomical abnormality 4. infection or hematoma at puncture site 5. patients who did not need internal jugular vein catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First access success rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insertion time | 10 minutes after the beginning of the procedure | defined as the time in seconds between the beginning of the procedure and guide-wire insertion |
| complication rate | 24 hours after surgery | incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein |
| ease of procedure | 10 minutes after the beginning of the 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) |
| The number of attempts | 10 minutes after the beginning of the procedure | The number of attempts was counted each time a subject inserted a guide needle into the neck surface, followed by withdrawal, redirection, or reinsertion. |
Countries
South Korea
Outcome results
None listed