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NCT00486096 Clinical Trial

Femoral Arterial Cannulation

Congenital Disorders Clinical Trial

Official title:
Femoral Arterial Cannulation in Infants Following Complicated Sternal Re-entry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00486096
Other study ID # 07-012
Secondary ID
Status Terminated
Phase N/A
First received June 12, 2007
Last updated March 14, 2012
Start date February 2007
Est. completion date August 2007

Study information
Verified date June 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- case report of successful angio-catheter use on 5 kg child

Exclusion Criteria:

- that which does not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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