Clinical trial NCT01742416: Ultrasound Assisted Arterial Cannulation in Small Children
Official title: Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Cannulation
Keywords: Arterial Cannulation
Ultrasound
Palpation Method
Pediatrics
Cardiac Surgery
Craniotomies
Cranial Vault Surgery
Abdominal Procedures
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Number of Attempts
timeFrame: Change from baseline to successful cannulation (estimated average of 30 minutes)
Secondary outcomes:
measure: Time to Successful Cannulation
timeFrame: Change from baseline to successful cannulation (estimated average of 30 minutes)
measure: Rate of Success of First Attempt
timeFrame: Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes)
measure: Number of Attempted Sites
timeFrame: Change from baseline to successful cannulation (estimated average of 30 minutes)
measure: Learning Curve
timeFrame: At approximately 4 months
measure: Cost of Procedure
timeFrame: Duration of the study (6 months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Katherine Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: