Objectives: To demonstrate that tissue ultrafiltration catheters are safe to place and use in an injured lower extremity, measure tissue pressures as well as the current standard of care, and effectively remove interstitial fluid for analysis of biomarkers.
Design: Institutional Review Board-approved, prospective pilot study.
Setting: Metropolitan Level I trauma center.
Patients: All patients who presented to the emergency department with a tibial fracture met the inclusion and exclusion criteria and gave informed consent were enrolled. A total of 10 patients were studied.
Intervention: All subjects were treated with two types of percutaneous intramuscular catheters in both the anterior and deep posterior compartments of the leg for 24 hours. One catheter was a conventional indwelling intramuscular pressure catheter (Stryker Quick Pressure Monitor, Kalamazoo, MI), whereas the other was an experimental combined pressure monitoring/tissue ultrafiltration catheter (Compartment Monitoring System [CMS] catheter; Twin Star Medical, Inc, Minneapolis, MN).
Main outcome measurements: Safety of device, intramuscular pressure values, and quantity of fluid removed (from CMS catheter only).
Results: No serious device-related complications occurred. There was reasonable correlation between the pressures measured by the CMS and Stryker catheters. Average decrease in intramuscular pressure from baseline to final pressure was 11.3 ± 2.8 mm Hg in the anterior compartment (P = 0.003 by two-tailed paired t test) and 5.9 ± 1.4 mm Hg in the deep posterior compartment (P = 0.01). Ultrafiltrate analysis revealed that lactate dehydrogenase and creatine kinase levels were markedly elevated over serum levels. No patient needed fasciotomy or developed compartment syndrome during the study period.
Conclusions: This pilot study of CMS catheters demonstrates safety of CMS catheter use. Assay of the ultrafiltrate may provide greater sensitivity to muscle injury; further research of this approach is warranted.