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Ultrasound-guided Arterial Catheterization in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02333786
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:
Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.

Condition or disease Intervention/treatment Phase
Ultrasound Arterial Catheterization Child Other: Long-axis/in-plane US-guided arterial catheterization Other: Short-axis/out-of-plane US-guided arterial catheterization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Infant
Radial artery or posterior tibial artery of patients younger than 1 year old are either cannulated with short-axis/out-of-plane or long-axis/in-plane US-guided arterial catheterization technique.
Other: Long-axis/in-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.

Other: Short-axis/out-of-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.

Experimental: Preschool child
Radial artery or posterior tibial artery of patients older than 1 year old and younger than 5 years old are either cannulated with long-axis/in-plane or short-axis/out-of-plane US-guided arterial catheterization technique.
Other: Long-axis/in-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.

Other: Short-axis/out-of-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.




Primary Outcome Measures :
  1. Arterial catheterization time [ Time Frame: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds ]

Secondary Outcome Measures :
  1. Ultrasound imaging time [ Time Frame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds ]
  2. Time to first puncture of the artery [ Time Frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds ]
  3. Number of puncture attempts [ Time Frame: Up to 5 times, an expected average observation time of 600 seconds ]


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery under general anesthesia
  • Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

  • Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
  • Peripheral vascular disease
  • Congenital aortic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333786


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD. PhD. Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin-Tae Kim, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02333786    
Other Study ID Numbers: H-1409-095-610
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015