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  • The Value of Automating the Lumbar Spinal Fluid Drainage Process: Initial Results of the FlowSafe Clinical Trial

    Final Number:

    Jan M. Eckermann MD; Thomas P. Lo MD; William J. Meyer PhD, MD; Tung Tran MD; Susan Schaufelberger NP

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2014 Annual Meeting

    Introduction: Cerebrospinal (CSF) leak is a complication following neurosurgical intervention and has a reported occurrence rate of 2%-30% (1-3). Lumbar drainage is an accepted method for treating CSF leaks, but current lumbar drains are fraught with human error (4) Both over-drainage and under-drainage of CSF carry significant risks. To minimize human error and increase patient safety, this trial evaluates the safety and efficacy of an automated, yet gravity-driven system to drain lumbar CSF.

    Methods: Within the guidelines of Kern Medical Center's IRB 24 consecutive patients requiring lumbar drainage were prospectively followed. Instead of using conventional, non-automated lumbar drains, the FlowSafe (BeckerSmith Medical, Irvine, CA) automated system was used. Recorded endpoints include cessation of CSF leak, symptoms of over-drainage or under-drainage, presence of infections, length of drainage, volume of drainage and length of stay in the intensive care unit and nursing staff satisfaction. The different underlying diagnoses of the study patients are listed in Figure 1.

    Results: 23 patients were successfully drained with the FlowSafe (Figure 2). One patient had symptoms of over-drainage at 10mL/hr drainage which subsided after drainage was reprogrammed to 5mL/hr. Total ICU days were 100; Forty-five of these were for reasons other than lumbar drainage (Figure 3). No nursing staff intervention was required in any patient. Nursing staff responded favorably to the FlowSafe because it decreased workload, anxiety, and allowed for more time spent on other tasks.

    Conclusions: The FlowSafe is an automated, yet gravity-driven CSF drainage system that appears to be safe. Due to the system's safety profile, it seems feasible to move lumbar drain patients to a less supervised setting and thus decrease healthcare costs (Figure 3).

    Patient Care: By automating a system that is fraught with human error, patient safety is increased and inherent risks minimized. Patients may be more comfortable in a less supervised setting and with a portable lumbar drainage system.

    Learning Objectives: By the conclusion of this session, participants should be able to: 1) Describe the incidence and mechanisms of CSF leaks 2) Discuss different methods of dealing with CSF leaks 3) Identify a novel, automated, gravity-driven system for CSF drainage

    References: 1. Miller RH. Complications of posterior fossa surgery. In Silvenstein H, Norrell H,eds. Neurological Surgery of the Ear. Birmingham, Ala.: Aesculapius; 1977:267-274. 2. Glasscock ME, Hays JW. The translabyrinthine removal of acoustic tumors and other cerebellopontine angle tumors. Ann Otol Rhinol Laryngol. 1973;82:415-427. 3. Selesnick SH, Liu JC, Jen A, Newman J. The incidence of cerebrospinal fluid leak after vestibular schwannoma surgery. Otology & Neurotology 25:387-393, 2004. 4. Roland PS, Marple BF, Meyerhoff WL et al. Complication of lumbar spinal drainage. Otolaryngol Head Neck Surg. 1992;107:564-569.

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