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Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg

NCT00681616 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-03-04

No results posted yet for this study

Summary

An investigation of a new catheter and pressure monitor system that may help to prevent a complication called compartment syndrome from developing in an injured leg. Compartment syndrome occurs when too much fluid builds up in the muscles of the injured leg. This causes a lot of swelling and increases pressures within the leg that can cause permanent damage muscles and nerves in the leg.

Conditions

  • Compartment Syndrome

Interventions

DEVICE

Compartment Monitoring System (CMS)

The CMS consists of an Introducer, Pressure Measurement \& Fluid Collection (PMFC) catheter, a Fluid Collection (FC) catheter and Compartment Pressure Monitor. The PMFC catheter removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The FC catheter only removes fluid and does not have a pressure transducer at the tip. The CMS Monitor senses, displays and records compartment pressure as measured by up to two PMFC catheters. In addition, the CMS Monitor measures subject blood pressure using a provided cuff for calculating the perfusion pressure of the muscle compartment.

DEVICE

Compartment Monitoring System with Active Fluid Removal

Compartment Monitoring System with Active Fluid Removal

DEVICE

Compartment Monitoring System without fluid removal

Compartment Monitoring System without fluid removal

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Twin Star Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Schmidt, MD · Hennepin County Medical Center (HCMC)

  • Janelle M Antil · Twin Star Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00681616 on ClinicalTrials.gov