Trial Outcomes & Findings for A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population (NCT NCT01680666)

NCT ID: NCT01680666

Last Updated: 2017-11-09

Results Overview

The count (%) of patients with successful central venous cannulation at first attempt is reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: Up to 410 seconds
• Results posted on: 2017-11-09

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	84	66
Overall Study COMPLETED	84	66
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Landmark Guided n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	84 Participants n=5 Participants	66 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8 years n=5 Participants	5 years n=7 Participants	7 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	43 Participants n=7 Participants	96 Participants n=5 Participants
Region of Enrollment United States	84 participants n=5 Participants	66 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 410 seconds

The count (%) of patients with successful central venous cannulation at first attempt is reported.

Outcome measures

Measure	Landmark Technique n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.
Success of Central Venous Cannulation at First Attempt	38 Participants	43 Participants

SECONDARY outcome

Timeframe: Up to 410 seconds

The count (%) of patients with successful central venous cannulation within the first three attempts is reported.

Outcome measures

Measure	Landmark Technique n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.
Success of Central Venous Cannulation Within First Three Attempts	62 Participants	63 Participants

SECONDARY outcome

Timeframe: Up to 410 seconds

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

Outcome measures

Measure	Landmark Technique n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.
Patients With Arterial Punctures	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 410 seconds

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

Outcome measures

Measure	Landmark Technique n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.
Patients With Complications	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 410 seconds

Outcome measures

Measure	Landmark Technique n=84 Participants 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.	Ultrasound Guided n=66 Participants 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.
Time to Successful Cannulation	42 seconds Interval 4.0 to 410.0	33 seconds Interval 2.0 to 220.0

Adverse Events

Landmark Guided

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound Guided

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Landmark Guided n=84 participants at risk 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.	Ultrasound Guided n=66 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hemothorax	0.00% 0/84 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events	1.5% 1/66 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events
Vascular disorders Hematoma (nonexpanding)	2.4% 2/84 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events	3.0% 2/66 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.4% 2/84 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events	0.00% 0/66 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events
Vascular disorders Arterial puncture	8.3% 7/84 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events	4.5% 3/66 • Up to 410 seconds Per protocol, procedure-related complications were reported as adverse events

Other adverse events

Adverse event data not reported

Additional Information

Matias Bruzoni, MD

Stanford University

Phone: 650-723-6439

Email: mbruzoni@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place