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

NCT02183857 | Completed

• 1 other identifier: ANES.SS.12
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

children; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• the time needed to achieve a successful cannulation of the femoral artery.

  The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer

Study Arms (2)

Ultrasound

OTHER

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)

Device: Ultrasound

Landmark

OTHER

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.

Other: Landmark

Interventions

Ultrasound DEVICE

Also known as: SonoSite 180 PLUS

Ultrasound

Landmark OTHER

Landmark

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants and children under 12 years of age.
• American Society of Anesthesiologist Physical Status (ASA) III or IV.
• Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.
• Parents/guardians/patients willing to sign consent.

You may not qualify if:

• Hematoma or infections at the potential site of insertion.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Need for emergency surgery.
• Hemodynamic instability

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sahar M Siddik-Sayyid, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

LE (1)