Ultrasound Assisted Arterial Cannulation in Small Children

NCT ID: NCT01742416

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultrasound

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

Arterial cannulation facilitated by ultrasound.

Palpation Method

Group Type: ACTIVE_COMPARATOR

Palpation Method

Intervention Type: PROCEDURE

Arterial cannulation by palpation method.

Interventions

Ultrasound

Arterial cannulation facilitated by ultrasound.

Intervention Type: PROCEDURE

Palpation Method

Arterial cannulation by palpation method.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Katherine Taylor

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000030723

Identifier Type: -

Identifier Source: org_study_id