Trial Outcomes & Findings for Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation (NCT NCT01966354)
NCT ID: NCT01966354
Last Updated: 2016-08-01
Results Overview
Cannulation will be considered as "successful" once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered "unsuccessful". This outcome measure will be registered at the end of the cannulation process.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
At the end of the cannulation process (180 seconds, maximum)
Results posted on
2016-08-01
Participant Flow
The day before IJVC was to be performed, patients (aged 18 or above) in whom IJVC had been indicated were asked to participate in the study. Patients who did not meet any exclusion criteria were included.
Participant milestones
| Measure |
Long Axis, In-plane Needle
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
73
|
72
|
|
Overall Study
COMPLETED
|
75
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation
Baseline characteristics by cohort
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
75 participants
n=5 Participants
|
73 participants
n=7 Participants
|
72 participants
n=5 Participants
|
220 participants
n=4 Participants
|
|
Cannulated IJV diameter (cm)
|
1.23 centimeters (cm)
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.20 centimeters (cm)
STANDARD_DEVIATION 0.3 • n=7 Participants
|
1.10 centimeters (cm)
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.20 centimeters (cm)
STANDARD_DEVIATION 0.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of the cannulation process (180 seconds, maximum)Cannulation will be considered as "successful" once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered "unsuccessful". This outcome measure will be registered at the end of the cannulation process.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Cannulation Success
|
73 participants
|
71 participants
|
68 participants
|
SECONDARY outcome
Timeframe: At the end of the cannulation process (180 seconds, maximum)Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Number of Cannulation Attempts
|
1.92 attempts
Standard Deviation 1.36
|
1.51 attempts
Standard Deviation 0.97
|
1.37 attempts
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: At the end of the cannulation process (180 seconds, maximum)Any cannulation that has been accomplished with a single cannulation attempt will be considered a "first attempt cannulation". This outcome measure will be registered at the end of the cannulation process.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
First Attempt Cannulation
|
39 participants
|
51 participants
|
53 participants
|
SECONDARY outcome
Timeframe: At the end of the cannulation process (180 seconds, maximum)Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Cannulation Time
|
46.1 seconds
Standard Deviation 36.3
|
35.0 seconds
Standard Deviation 23.4
|
41.2 seconds
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: At the end of the cannulation process (180 seconds, maximum)The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Mechanical Complications
|
3 participants
|
11 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Once the central venous catheter is withdrawn (2 months)The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.
Outcome measures
| Measure |
Long Axis, In-plane Needle
n=75 Participants
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 Participants
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 Participants
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Infectious Complications
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
Long Axis, In-plane Needle
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Short Axis, Out-of-plane Needle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Oblique Axis, In-plane Needle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Long Axis, In-plane Needle
n=75 participants at risk
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 participants at risk
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 participants at risk
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Infections and infestations
Catheter-related blood stream infection
|
2.7%
2/75
|
0.00%
0/73
|
0.00%
0/72
|
Other adverse events
| Measure |
Long Axis, In-plane Needle
n=75 participants at risk
Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Short Axis, Out-of-plane Needle
n=73 participants at risk
Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
Oblique Axis, In-plane Needle
n=72 participants at risk
Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).
|
|---|---|---|---|
|
Vascular disorders
Posterior internal jugular venous wall puncture
|
0.00%
0/75
|
11.0%
8/73
|
1.4%
1/72
|
|
Blood and lymphatic system disorders
Puncture site bleeding
|
1.3%
1/75
|
2.7%
2/73
|
0.00%
0/72
|
|
Blood and lymphatic system disorders
Local cervical haematoma
|
2.7%
2/75
|
1.4%
1/73
|
2.8%
2/72
|
|
Vascular disorders
Catheter misplacement
|
2.7%
2/75
|
0.00%
0/73
|
2.8%
2/72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place