An interventional study of Ultrasound-guided Internal jugular venous approach in Ultrasound-guided Internal Jugular Cannulation and Central Venous Access Complications, sponsored by Mikel Batllori. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-01.
Sponsored by Mikel Batllori · Not applicable, Interventional, and Prevention
The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.
This is the only study on the registry with Mikel Batllori as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Ultrasound-guided Internal jugular venous approach
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).
Procedure: Ultrasound-guided Internal jugular venous approach
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.
Procedure: 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
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.
Time frame: At the end of the cannulation process (180 seconds, maximum)
Number of Cannulation Attempts
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.
Time frame: At the end of the cannulation process (180 seconds, maximum)
First Attempt Cannulation
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.
Time frame: At the end of the cannulation process (180 seconds, maximum)
Cannulation Time
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.
Time frame: At the end of the cannulation process (180 seconds, maximum)
Mechanical Complications
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.
Time frame: At the end of the cannulation process (180 seconds, maximum)
Infectious Complications
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.
Time frame: Once the central venous catheter is withdrawn (2 months)
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.
| Milestone | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Started | 75 | 73 | 72 |
| Completed | 75 | 73 | 72 |
| Not completed | 0 | 0 | 0 |
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.
| participants | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Cannulation Success | 73 | 71 | 68 |
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.
| attempts | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Number of Cannulation Attempts | 1.92 ± 1.36 | 1.51 ± 0.97 | 1.37 ± 0.84 |
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.
| participants | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| First Attempt Cannulation | 39 | 51 | 53 |
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.
| seconds | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Cannulation Time | 46.1 ± 36.3 | 35.0 ± 23.4 | 41.2 ± 23.9 |
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.
| participants | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Mechanical Complications | 3 | 11 | 5 |
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.
| participants | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Infectious Complications | 2 | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Long Axis, In-plane Needle | — | 2/75 (2.7%) | 5/75 (6.7%) |
| Short Axis, Out-of-plane Needle | — | 0/73 (0%) | 11/73 (15.1%) |
| Oblique Axis, In-plane Needle | — | 0/72 (0%) | 5/72 (6.9%) |
| Event | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Catheter-related blood stream infectionInfections and infestations | 2/75 | 0/73 | 0/72 |
| Event | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle |
|---|---|---|---|
| Posterior internal jugular venous wall punctureVascular disorders | 0/75 | 8/73 | 1/72 |
| Local cervical haematomaBlood and lymphatic system disorders | 2/75 | 1/73 | 2/72 |
| Catheter misplacementVascular disorders | 2/75 | 0/73 | 2/72 |
| Puncture site bleedingBlood and lymphatic system disorders | 1/75 | 2/73 | 0/72 |
| Age, Continuous(years) | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| Mean | 64 ± 13.6 | 64.9 ± 13.6 | 65.2 ± 15.0 | 64.7 ± 14.0 |
| Sex: Female, Male(Participants) | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| Female | 26 | 28 | 29 | 83 |
| Male | 49 | 45 | 43 | 137 |
| Race (NIH/OMB)(Participants) | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 75 | 73 | 72 | 220 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| Spain | 75 | 73 | 72 | 220 |
| Cannulated IJV diameter (cm)(centimeters (cm)) | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| Mean | 1.23 ± 0.3 | 1.20 ± 0.3 | 1.10 ± 0.2 | 1.20 ± 0.3 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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