Central Venous Access Complications, Ultrasound-guided Internal Jugular Cannulation
Conditions
Keywords
adult, catheterization, central venous, ultrasonography, interventional, evidence-based medicine, cost-benefit analysis
Brief summary
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.
Interventions
PROCEDUREUltrasound-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).
Sponsors
Instituto de Salud Carlos III
Mikel Batllori
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 or older * Indication for internal jugular venous cannulation, previously established by the doctor responsible for the patient´s hospital diagnosis and treatment * Informed consent for trial participation has been obtained from the patient
Exclusion criteria
* Infection signs at or close to puncture site * Cutaneous erosions or subcutaneous haematoma at or close to puncture site * History of internal jugular venous cannulation during the past 72 hours (in the same side in which the present cannulation is taking place) * History of previous surgical interventions on the cannulation site * Recent cervical trauma with present neck immobilization and without having ruled out eventual cervical spinal injury * Severe coagulopathy (altered coagulation parameters and active bleeding) which cannot be promptly corrected by platelet, fresh frozen plasma or pharmacologic intervention * Subcutaneous emphysema with cervical extension * Agitated or uncooperative patient (including deep sedation) * Inability to obtain formal informed consent from the patient or his legally authorized representative (in case the patient is legally incompetent to give informed consent) * Cannulation being performed outside the surgical area or the post-anesthesia care unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannulation Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cannulation Attempts | 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. |
| First Attempt Cannulation | 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. |
| Cannulation Time | 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. |
| Mechanical Complications | 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. |
| Infectious Complications | 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. |
Countries
Spain
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 75 |
| 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). | 73 |
| 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). | 72 |
| Total | 220 |
Baseline characteristics
| Characteristic | Long Axis, In-plane Needle | Short Axis, Out-of-plane Needle | Oblique Axis, In-plane Needle | Total |
|---|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 13.6 | 64.9 years STANDARD_DEVIATION 13.6 | 65.2 years STANDARD_DEVIATION 15 | 64.7 years STANDARD_DEVIATION 14 |
| Cannulated IJV diameter (cm) | 1.23 centimeters (cm) STANDARD_DEVIATION 0.3 | 1.20 centimeters (cm) STANDARD_DEVIATION 0.3 | 1.10 centimeters (cm) STANDARD_DEVIATION 0.2 | 1.20 centimeters (cm) STANDARD_DEVIATION 0.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 75 Participants | 73 Participants | 72 Participants | 220 Participants |
| Region of Enrollment Spain | 75 participants | 73 participants | 72 participants | 220 participants |
| Sex: Female, Male Female | 26 Participants | 28 Participants | 29 Participants | 83 Participants |
| Sex: Female, Male Male | 49 Participants | 45 Participants | 43 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 75 | 11 / 73 | 5 / 72 |
| serious Total, serious adverse events | 2 / 75 | 0 / 73 | 0 / 72 |
Outcome results
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Axis, In-plane Needle | Cannulation Success | 73 participants |
| Short Axis, Out-of-plane Needle | Cannulation Success | 71 participants |
| Oblique Axis, In-plane Needle | Cannulation Success | 68 participants |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Long Axis, In-plane Needle | Cannulation Time | 46.1 seconds | Standard Deviation 36.3 |
| Short Axis, Out-of-plane Needle | Cannulation Time | 35.0 seconds | Standard Deviation 23.4 |
| Oblique Axis, In-plane Needle | Cannulation Time | 41.2 seconds | Standard Deviation 23.9 |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Axis, In-plane Needle | First Attempt Cannulation | 39 participants |
| Short Axis, Out-of-plane Needle | First Attempt Cannulation | 51 participants |
| Oblique Axis, In-plane Needle | First Attempt Cannulation | 53 participants |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Axis, In-plane Needle | Infectious Complications | 2 participants |
| Short Axis, Out-of-plane Needle | Infectious Complications | 0 participants |
| Oblique Axis, In-plane Needle | Infectious Complications | 0 participants |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Axis, In-plane Needle | Mechanical Complications | 3 participants |
| Short Axis, Out-of-plane Needle | Mechanical Complications | 11 participants |
| Oblique Axis, In-plane Needle | Mechanical Complications | 5 participants |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Long Axis, In-plane Needle | Number of Cannulation Attempts | 1.92 attempts | Standard Deviation 1.36 |
| Short Axis, Out-of-plane Needle | Number of Cannulation Attempts | 1.51 attempts | Standard Deviation 0.97 |
| Oblique Axis, In-plane Needle | Number of Cannulation Attempts | 1.37 attempts | Standard Deviation 0.84 |