Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery

NCT ID: NCT02183857

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-01-31

Brief Summary

The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.

Detailed Description

The insertion of percutaneous femoral catheter is the method of choice for arterial monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut Medical Center. It is easier to access since it is a bigger vessel and matches better the aortic pressure immediately post initiation of bypass than the radial artery. Utilizing ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4 trials showed that, ultrasound guidance for radial artery catheterization improved first-pass success rate compared to the palpation method (2). Two of these trials were for pediatric patients where in one study ultrasound-guided radial arterial cannulation in 30 small children improved success rate with fewer attempts required with the ultrasound technique than with the traditional technique (3). However, in another study of 152 children under 12 years of age requiring radial artery cannulation, there were no statistically significant differences between the groups in time to successful cannulation, total number of attempts, number of successful cannulations during the first attempt, or in the number of cannulae used for catheterization (4). No previous study compared the use of ultrasound guidance vs landmark for femoral artery cannulation in the pediatric age group in particular for the teaching of anesthesia residents.

The hypothesis is that the use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.

The investigators will design a prospective randomized trial to compare the use of ultrasound guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or infections at the potential site of insertion, need for emergency surgery, and hemodynamic instability.

The risks to subjects include no more than the usual risks of arterial cannulation (infection and hematoma formation). Adverse events will be monitored, reported and treated appropriately.

Privacy and confidentiality will be respected. Data will be kept under lock with the primary investigator.

Conditions

Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery

Study Design

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

Study Groups

Ultrasound

Patients in group Ultrasound will have their femoral arterial lines inserted under the guidance of US. The Ultrasound equipment used is a SonoSite 180 PLUS with an L25/10- to 5-MHz linear array transducer (SonoSite, Inc., Bothell, WA)

Group Type: OTHER

Ultrasound

Intervention Type: DEVICE

Landmark

No Device is used. Patients in group Landmark will have their femoral line inserted using the blinded, external landmark-guided technique. After localization of the femoral artery by identifying the pulse in the femoral triangle immediately distal to the inguinal ligament.

Group Type: OTHER

Landmark

Intervention Type: OTHER

Interventions

Ultrasound

Intervention Type: DEVICE

Landmark

Intervention Type: OTHER

Other Intervention Names

SonoSite 180 PLUS

Eligibility Criteria

Inclusion Criteria

1. Infants and children under 12 years of age.

2. American Society of Anesthesiologist Physical Status (ASA) III or IV.

3. Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.

4. Parents/guardians/patients willing to sign consent.

Exclusion Criteria

1. Hematoma or infections at the potential site of insertion.

2. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

3. Need for emergency surgery.

4. Hemodynamic instability

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sahar Sayyid

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar M Siddik-Sayyid, MD

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Locations

American University of Beirut Medical center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

ANES.SS.12

Identifier Type: -

Identifier Source: org_study_id