Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-03-14 @ 5:47 AM
Study NCT ID:
NCT02183857
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2014-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery
Sponsor:
American University of Beirut Medical Center
Organization:
Study Overview
Official Title:
Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: