Ultrasound Assisted Arterial Cannulation in Small Children

Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?

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.

Study Overview

• Status: Completed
• Conditions: Arterial Cannulation
• Intervention / Treatment: Procedure: Ultrasound; Procedure: Palpation Method

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasound	Procedure: Ultrasound; Arterial cannulation facilitated by ultrasound.
ACTIVE_COMPARATOR: Palpation Method	Procedure: Palpation Method; Arterial cannulation by palpation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Attempts	To measure the number of attempts to cannulate the artery per participant.	Change from baseline to successful cannulation (estimated average of 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Successful Cannulation	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.	Change from baseline to successful cannulation (estimated average of 30 minutes)
Rate of Success of First Attempt	The rate of success of first attempt to cannulate the artery of each participant.	Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes)
Number of Attempted Sites	To measure the total number of attempted sites.	Change from baseline to successful cannulation (estimated average of 30 minutes)
Learning Curve	To measure the learning curve for each of the participating anaesthetist.	At approximately 4 months
Cost of Procedure	To measure the estimated cost of the procedure.	Duration of the study (6 months)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Katherine Taylor, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Pediatrics; Cardiac Surgery; Craniotomies; Arterial Cannulation; Palpation Method; Cranial Vault Surgery; Abdominal Procedures
• Other Study ID Numbers: 1000030723