Ultrasound Assisted Arterial Cannulation in Small Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Katherine Taylor, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01742416
First received: November 30, 2012
Last updated: May 31, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?

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

Primary Outcome Measures:
  • Number of Attempts [ Time Frame: Change from baseline to successful cannulation (estimated average of 30 minutes) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    To measure the total number of attempted sites.

  • Learning Curve [ Time Frame: At approximately 4 months ] [ Designated as safety issue: No ]
    To measure the learning curve for each of the participating anaesthetist.

  • Cost of Procedure [ Time Frame: Duration of the study (6 months) ] [ Designated as safety issue: No ]
    To measure the estimated cost of the procedure.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated 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

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742416

Contacts
Contact: Katherine Taylor, MD (416)813-7654 ext 2453 katherine.taylor@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Katherine Taylor, MD    (416)813-7654 ext 2453    katherine.taylor@sickkids.ca   
Principal Investigator: Katherine Taylor, MD         
Sub-Investigator: Jens Aage Kolsen Petersen, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Katherine Taylor, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01742416     History of Changes
Other Study ID Numbers: 1000030723
Study First Received: November 30, 2012
Last Updated: May 31, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 28, 2014