Need for Central Venous Access
Conditions
Brief summary
The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.
Interventions
central line placement
Ultrasound guided central venous access
Sponsors
Study design
Eligibility
Inclusion criteria
* All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia
Exclusion criteria
* Preoperative proof of non-patency of central veins * coagulopathy * access site surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Central Venous Cannulation at First Attempt | Up to 410 seconds | The count (%) of patients with successful central venous cannulation at first attempt is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of Central Venous Cannulation Within First Three Attempts | Up to 410 seconds | The count (%) of patients with successful central venous cannulation within the first three attempts is reported. |
| Patients With Arterial Punctures | Up to 410 seconds | The count (%) of patients with arterial punctures is presented. |
| Patients With Complications | Up to 410 seconds | The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented. |
| Time to Successful Cannulation | Up to 410 seconds | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Landmark Guided In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air. | 84 |
| Ultrasound Guided In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site. | 66 |
| Total | 150 |
Baseline characteristics
| Characteristic | Ultrasound Guided | Landmark Guided | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 66 Participants | 84 Participants | 150 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5 years | 8 years | 7 years |
| Region of Enrollment United States | 66 participants | 84 participants | 150 participants |
| Sex: Female, Male Female | 23 Participants | 31 Participants | 54 Participants |
| Sex: Female, Male Male | 43 Participants | 53 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 84 | 0 / 66 |
| serious Total, serious adverse events | 11 / 84 | 6 / 66 |
Outcome results
Success of Central Venous Cannulation at First Attempt
The count (%) of patients with successful central venous cannulation at first attempt is reported.
Time frame: Up to 410 seconds
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Landmark Technique | Success of Central Venous Cannulation at First Attempt | 38 Participants |
| Ultrasound Guided | Success of Central Venous Cannulation at First Attempt | 43 Participants |
Patients With Arterial Punctures
The count (%) of patients with arterial punctures is presented.
Time frame: Up to 410 seconds
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Landmark Technique | Patients With Arterial Punctures | 7 Participants |
| Ultrasound Guided | Patients With Arterial Punctures | 3 Participants |
Patients With Complications
The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
Time frame: Up to 410 seconds
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Landmark Technique | Patients With Complications | 4 Participants |
| Ultrasound Guided | Patients With Complications | 3 Participants |
Success of Central Venous Cannulation Within First Three Attempts
The count (%) of patients with successful central venous cannulation within the first three attempts is reported.
Time frame: Up to 410 seconds
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Landmark Technique | Success of Central Venous Cannulation Within First Three Attempts | 62 Participants |
| Ultrasound Guided | Success of Central Venous Cannulation Within First Three Attempts | 63 Participants |
Time to Successful Cannulation
Time frame: Up to 410 seconds
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Landmark Technique | Time to Successful Cannulation | 42 seconds |
| Ultrasound Guided | Time to Successful Cannulation | 33 seconds |