Ultrasound Assisted Arterial Cannulation in Small Children

Study Overview
=================
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.

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

Conditions
-----------------
Arterial Cannulation

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: Palpation Method


Participation Criteria
=================
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 Pulmonary hypertension defined as an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure Children with severe heart failure (right and/or left)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br> | Procedure: Ultrasound<br>* Arterial cannulation facilitated by ultrasound.<br>|
| Active Comparator: Palpation Method<br> | Procedure: Palpation Method<br>* Arterial cannulation by palpation method.<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial Cannulation, Ultrasound, Palpation Method, Pediatrics, Cardiac Surgery, Craniotomies, Cranial Vault Surgery, Abdominal Procedures