A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs

Diaphyseal Femur Fracture Clinical Trial

Official title:

Using Transesophageal Echocardiography To Assess Fat Emboli As A Result Of Reaming In A Prospective Randomized Control Trial To Determine The Effectiveness Of Reaming In Diminishing Fat Emboli To The Lungs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327158
• Other study ID #: 06-0296-F1V
• Status: Completed
• Phase: N/A
• First received: May 16, 2006
• Last updated: January 27, 2010
• Start date: May 2006
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.

Description:

Reamed intramedullary nailing of diaphyseal femur fractures remains the standard of care for treatment of these fractures. Pressurization of the femoral canal during reaming leads to extra vasations of fat emboli into the systemic circulation, resulting in deposition of fat droplets in the pulmonary vasculature. This phenomenon has been well documented by use of Transesophageal Echocardiography. A novel reaming system has recently become available that may limit this phenomenon. The new reamer system incorporates irrigation and aspiration during reaming, theoretically minimizing pressurization and fat emboli. Additionally, this reamer system allows for one pass reaming as compared to the current system which requires multiple reaming passes.

The objective of this study is to determine effectiveness of reaming in diminishing fat emboli to the lungs as evidenced by decreased numbers of large fat droplets entering the right heart as measured by transesophageal echocardiography during the reaming process. This will determine if there is a benefit to aspiration during reaming as would be expected.

During the reaming process a transesophageal echo cardiogram will be performed to analyze the presence or absence of emboli and the mean regarding the total time that each of the embolic grades is present during each of the intervals across the patient groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diaphyseal femur fractures undergoing reamed intramedullary nailing

• male or female

• 18 years of age or older

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diaphyseal Femur Fracture
• Femoral Fractures

Intervention

Procedure:
• Transesophageal transducer
One time use of reamer during surgery
• echocardiography
takes photos of right atrium during the reaming processes

Locations

Country	Name	City	State
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Emboli		Immediately following surgery	Yes