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

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ClinicalTrials.gov Identifier: NCT01680666
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : February 11, 2015
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Matias Bruzoni, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Need for Central Venous Access
Interventions Procedure: central line placement
Device: Ultrasound
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 84 66
Completed 84 66
Not Completed 0 0
Arm/Group Title Landmark Guided Ultrasound Guided Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 84 66 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 66 participants 150 participants
<=18 years
84
 100.0%
66
 100.0%
150
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 66 participants 150 participants
8
(0 to 18)
5
(0 to 18)
7
(0 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 66 participants 150 participants
Female
31
  36.9%
23
  34.8%
54
  36.0%
Male
53
  63.1%
43
  65.2%
96
  64.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 84 participants 66 participants 150 participants
84 66 150
1.Primary Outcome
Title Success of Central Venous Cannulation at First Attempt
Hide Description The count (%) of patients with successful central venous cannulation at first attempt is reported.
Time Frame Up to 410 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Landmark Technique Ultrasound Guided
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 84 66
Measure Type: Count of Participants
Unit of Measure: Participants
38
  45.2%
43
  65.2%
2.Secondary Outcome
Title Success of Central Venous Cannulation Within First Three Attempts
Hide Description The count (%) of patients with successful central venous cannulation within the first three attempts is reported.
Time Frame Up to 410 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 84 66
Measure Type: Count of Participants
Unit of Measure: Participants
62
  73.8%
63
  95.5%
3.Secondary Outcome
Title Patients With Arterial Punctures
Hide Description The count (%) of patients with arterial punctures is presented.
Time Frame Up to 410 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 84 66
Measure Type: Count of Participants
Unit of Measure: Participants
7
   8.3%
3
   4.5%
4.Secondary Outcome
Title Patients With Complications
Hide Description The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
Time Frame Up to 410 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 84 66
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.8%
3
   4.5%
5.Secondary Outcome
Title Time to Successful Cannulation
Hide Description [Not Specified]
Time Frame Up to 410 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 84 66
Mean (Full Range)
Unit of Measure: seconds
42
(4 to 410)
33
(2 to 220)
Time Frame Up to 410 seconds
Adverse Event Reporting Description Per protocol, procedure-related complications were reported as adverse events
 
Arm/Group Title Landmark Guided Ultrasound Guided
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Landmark Guided Ultrasound Guided
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Landmark Guided Ultrasound Guided
Affected / at Risk (%) Affected / at Risk (%)
Total   11/84 (13.10%)   6/66 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Hemothorax   0/84 (0.00%)  1/66 (1.52%) 
Pneumothorax   2/84 (2.38%)  0/66 (0.00%) 
Vascular disorders     
Hematoma (nonexpanding)   2/84 (2.38%)  2/66 (3.03%) 
Arterial puncture   7/84 (8.33%)  3/66 (4.55%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Landmark Guided Ultrasound Guided
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/66 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matias Bruzoni, MD
Organization: Stanford University
Phone: 650-723-6439
EMail: mbruzoni@stanford.edu
Layout table for additonal information
Responsible Party: Matias Bruzoni, Stanford University
ClinicalTrials.gov Identifier: NCT01680666     History of Changes
Other Study ID Numbers: IRB-8943
First Submitted: August 28, 2012
First Posted: September 7, 2012
Results First Submitted: January 26, 2015
Results First Posted: February 11, 2015
Last Update Posted: November 9, 2017