Ultrasound Assisted Arterial Cannulation in Small Children

NCT01742416 | Completed

• 1 other identifier: 1000030723
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Cannulation

Keywords

Arterial Cannulation; Ultrasound; Palpation Method; Pediatrics; Cardiac Surgery; Craniotomies; Cranial Vault Surgery; Abdominal Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to Successful Cannulation

  Change from baseline to successful cannulation (estimated average of 30 minutes)

• Rate of Success of First Attempt

  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

  Change from baseline to successful cannulation (estimated average of 30 minutes)

• Learning Curve

  At approximately 4 months

• Cost of Procedure

  Duration of the study (6 months)

Study Arms (2)

Ultrasound

EXPERIMENTAL

Procedure: Ultrasound

Palpation Method

ACTIVE COMPARATOR

Procedure: Palpation Method

Interventions

Ultrasound PROCEDURE

Arterial cannulation facilitated by ultrasound.

Ultrasound

Palpation Method PROCEDURE

Arterial cannulation by palpation method.

Palpation Method

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Katherine Taylor, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 5, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CA (1)