Ultrasound Assisted Arterial Cannulation in Small Children

Arterial Cannulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742416
• Other study ID #: 1000030723
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Cannulation

Intervention

Procedure:
• Ultrasound
Arterial cannulation facilitated by ultrasound.
• Palpation Method
Arterial cannulation by palpation method.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Number of Attempted Sites	To measure the total number of attempted sites.	Change from baseline to successful cannulation (estimated average of 30 minutes)
Secondary	Learning Curve	To measure the learning curve for each of the participating anaesthetist.	At approximately 4 months
Secondary	Cost of Procedure	To measure the estimated cost of the procedure.	Duration of the study (6 months)