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A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population

A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680666
Enrollment
150
Registered
2012-09-07
Start date
2009-05-31
Completion date
2011-12-31
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Need for Central Venous Access

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

PROCEDUREcentral line placement

central line placement

DEVICEUltrasound

Ultrasound guided central venous access

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Success of Central Venous Cannulation at First AttemptUp to 410 secondsThe count (%) of patients with successful central venous cannulation at first attempt is reported.

Secondary

MeasureTime frameDescription
Success of Central Venous Cannulation Within First Three AttemptsUp to 410 secondsThe count (%) of patients with successful central venous cannulation within the first three attempts is reported.
Patients With Arterial PuncturesUp to 410 secondsThe count (%) of patients with arterial punctures is presented.
Patients With ComplicationsUp to 410 secondsThe count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
Time to Successful CannulationUp to 410 seconds

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total150

Baseline characteristics

CharacteristicUltrasound GuidedLandmark GuidedTotal
Age, Categorical
<=18 years
66 Participants84 Participants150 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous5 years8 years7 years
Region of Enrollment
United States
66 participants84 participants150 participants
Sex: Female, Male
Female
23 Participants31 Participants54 Participants
Sex: Female, Male
Male
43 Participants53 Participants96 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 840 / 66
serious
Total, serious adverse events
11 / 846 / 66

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Landmark TechniqueSuccess of Central Venous Cannulation at First Attempt38 Participants
Ultrasound GuidedSuccess of Central Venous Cannulation at First Attempt43 Participants
Secondary

Patients With Arterial Punctures

The count (%) of patients with arterial punctures is presented.

Time frame: Up to 410 seconds

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Landmark TechniquePatients With Arterial Punctures7 Participants
Ultrasound GuidedPatients With Arterial Punctures3 Participants
Secondary

Patients With Complications

The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.

Time frame: Up to 410 seconds

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Landmark TechniquePatients With Complications4 Participants
Ultrasound GuidedPatients With Complications3 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Landmark TechniqueSuccess of Central Venous Cannulation Within First Three Attempts62 Participants
Ultrasound GuidedSuccess of Central Venous Cannulation Within First Three Attempts63 Participants
Secondary

Time to Successful Cannulation

Time frame: Up to 410 seconds

ArmMeasureValue (MEAN)
Landmark TechniqueTime to Successful Cannulation42 seconds
Ultrasound GuidedTime to Successful Cannulation33 seconds

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026