- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486096
Femoral Arterial Cannulation
Femoral Arterial Cannulation in Infants Following Complicated Sternal Re-entry
Many children undergoing surgery for congenital heart disease have had prior operations. Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent peripheral cannulation.
Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in cases of complicated sternal re-entry in children and that angio-catheters can be utilized when vessels are too small for standard cannulas.
Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg child.
Study Overview
Status
Conditions
Detailed Description
In children, many of the standard operative sites are either occluded, stenosed, or too small for the smallest manufactured cannulas. In these instances, it may be feasible to utilize angio-catheters for arterial access until central cannulation can be achieved safely. In an in vitro model, we have simulated a cardiopulmonary bypass circuit and arterial cannulation with angio-catheters.
It appears that angio-catheters may be used with acceptable flow hemodynamics for blood vessels too small for standard cannulas.
We have performed this successfully in a 5 kg child.
We have completed the cardiopulmonary bypass model and are ready to submit the hemodynamic data. We would like to submit to a national meeting and hopefully for publication thereafter.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Children's Healthcare of Atlanta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- case report of successful angio-catheter use on 5 kg child
Exclusion Criteria:
- that which does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian E Kogon, MD, Emory Univ. / Children's Healthcare of Atlanta
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 07-012
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