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Ultrasound Assisted Arterial Cannulation in Small Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742416
First Posted: December 5, 2012
Last Update Posted: December 23, 2014
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.
Information provided by (Responsible Party):
Katherine Taylor, The Hospital for Sick Children
  Purpose
Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. This procedure can be challenging even in the best of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse may, however be weak or absent in patients with hypotension, edema, obesity or local thrombosis due to previous arterial cannulation in the same location. Furthermore, the catheter may not be passed successfully into the artery, despite apparent good blood return on initial puncture, or hematoma and spasms of the artery may develop after failed attempts, thus making further attempts even more difficult. While ultrasound (US) is being used with increasing frequency for central venous access, fewer clinicians are familiar with US-guided arterial catheterization. The aim of this study is to investigate if ultrasound facilitates arterial cannulation in children ≤24 months compared with the palpation method and to investigate the potential extra costs/savings of introducing the method. This study hypothesizes that the ultrasound method will facilitate arterial cannulation in small children compared with the palpation method.

Condition Intervention
Arterial Cannulation Procedure: Ultrasound Procedure: Palpation Method

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?

Resource links provided by NLM:


Further study details as provided by Katherine Taylor, The Hospital for Sick Children:

Primary Outcome Measures:
  • Number of Attempts [ Time Frame: Change from baseline to successful cannulation (estimated average of 30 minutes) ]
    To measure the number of attempts to cannulate the artery per participant.


Secondary Outcome Measures:
  • Time to Successful Cannulation [ Time Frame: Change from baseline to successful cannulation (estimated average of 30 minutes) ]
    To measure the difference between the time when the palpating finger touches the skin (palpation group) or the gel is applied to the skin (US group) at the first intended cannulation site and the time when the arterial cannula is correctly in place.

  • Rate of Success of First Attempt [ Time Frame: Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes) ]
    The rate of success of first attempt to cannulate the artery of each participant.

  • Number of Attempted Sites [ Time Frame: Change from baseline to successful cannulation (estimated average of 30 minutes) ]
    To measure the total number of attempted sites.

  • Learning Curve [ Time Frame: At approximately 4 months ]
    To measure the learning curve for each of the participating anaesthetist.

  • Cost of Procedure [ Time Frame: Duration of the study (6 months) ]
    To measure the estimated cost of the procedure.


Enrollment: 40
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Procedure: Ultrasound
Arterial cannulation facilitated by ultrasound.
Active Comparator: Palpation Method Procedure: Palpation Method
Arterial cannulation by palpation method.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 24 months or younger
  • Children undergoing elective surgical procedures where arterial cannulation is planned by the attending anaesthetist. These procedures include cardiac surgery, craniotomies, cranial vault surgery, and some abdominal procedures.

Exclusion Criteria:

  • Refusal of consent from the parents
  • Refusal of participation from the anaesthetist
  • Children with anticipated circulatory instability after anaesthesia induction

    1. Pulmonary hypertension defined as an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
    2. Children with severe heart failure (right and/or left)
  Contacts and Locations
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): NCT01742416


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Katherine Taylor, MD The Hospital for Sick Children
  More Information

Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01742416     History of Changes
Other Study ID Numbers: 1000030723
First Submitted: November 30, 2012
First Posted: December 5, 2012
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Katherine Taylor, The Hospital for Sick Children:
Arterial Cannulation
Ultrasound
Palpation Method
Pediatrics
Cardiac Surgery
Craniotomies
Cranial Vault Surgery
Abdominal Procedures