Ultrasound Assisted Arterial Cannulation in Small Children
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 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?|
- 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.
- 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.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Arterial cannulation facilitated by ultrasound.
|Active Comparator: Palpation Method||
Procedure: Palpation Method
Arterial cannulation by palpation method.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742416
|Contact: Katherine Taylor, MD||(416)813-7654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Katherine Taylor, MD (416)813-7654 ext 2453 email@example.com|
|Principal Investigator: Katherine Taylor, MD|
|Sub-Investigator: Jens Aage Kolsen Petersen, MD|
|Principal Investigator:||Katherine Taylor, MD||The Hospital for Sick Children|