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The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795468
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center

Brief Summary:
The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Condition or disease Intervention/treatment Phase
Catheterization, Peripheral Procedure: Radial arterial cannulation Not Applicable

Detailed Description:
In infants (<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
Study Start Date : June 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Palpation group
The operator will use the pulsation of the radial artery as a guide for the cannulation.
Procedure: Radial arterial cannulation
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Experimental: Ultrasound group
The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter.
Procedure: Radial arterial cannulation
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group




Primary Outcome Measures :
  1. First-pass success rate [ Time Frame: Within 10 min from the start time of arterial cannulation using an angiocath ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria:

  • Sign of a skin infection
  • Wound near the puncture site
  • abnormal circulation of the hand
  • any vascular problem at radial or ulnar artery

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): NCT02795468


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong Hwan Lee Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jong Hwan Lee, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02795468    
Other Study ID Numbers: 2016-03-128-001
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Jong Hwan Lee, Samsung Medical Center:
Peripheral
Arterial
Catheterization