Study Finds ShuntCheck is an Effective Aid for Emergency Room Doctors

Study Finds ShuntCheck is an effective aid for emergency room doctors in determining the need for surgical intervention in a possible shunt failure.

The most common treatment for hydrocephalus is the surgical placement of a shunt into the brain. The shunt diverts the excess cerebral spinal fluid away from the brain, where the body can naturally absorb it. Shunts save lives and are successful for most people, but when a shunt fails, it can be life-threatening.  An estimated 50% of shunts in the pediatric population fail within two years of placement and repeated neurosurgical operations are often required.

The symptoms of shunt failure are unspecific, including headaches and nausea. This leads to a frightening dilemma for individuals with hydrocephalus and their loved ones – is this just a headache or a life-threatening shunt blockage? In order to be sure, patients rush to the hospital emergency department (ED) to be evaluated. Most patients will receive a series of tests that include CT and MRI scans which are expensive. A noninvasive means to test whether fluid is flowing through the shunt system can quickly rule out a shunt blockage and the need for surgery in many patients.

A multi-site, prospective, operator-blinded clinical study, funded by a National Institutes of Health grant, was conducted at ten children’s hospitals using ShuntCheck, a non-invasive device that uses temperature to check fluid flow through the distal catheter. The study goal was to determine the effectiveness of ShuntCheck as an aid in determining the need for a shunt revision. The device is a simple design, resembling the shape of a knuckle band aid, that contains a sensor that collects skin temperature data. The sensor is placed on the collar bone directly over the shunt tubing, then a cold pack is placed on the neck just “upstream” of the sensor, chilling the shunt fluid through the skin. If the shunt is flowing, the now cooled fluid moves downstream to the sensor and registers as a temperature drop, indicating flow. If the shunt is not flowing, the cooled fluid remains upstream, so no drop in temperature will be recorded. This test is simple to perform and can be administered in the ED at bedside.

The study enrolled 406 patients in which 391 were evaluated with ShuntCheck. Prior to any imaging, patients were first evaluated by the attending physician to determine the likelihood of the patient needing to go on to receive surgical intervention (unlikely/not unlikely). The patients were then assessed using ShuntCheck to determine if there was fluid flow in the distal catheter. All patients went on to receive imaging to compare the decision for surgical intervention using evaluation and ShuntCheck alone versus results that included the information from the neuroimaging. In the patients who were deemed unlikely to need surgery on initial evaluation and who also showed flow through their catheter using ShuntCheck, the study showed 100% accuracy in ruling out a shunt obstruction and the need for imaging and other invasive tests or surgery. Therefore, it was determined that it can be used in conjunction with clinical judgment as a “confirmatory rule out test”, which would either confirm physician judgement or confirm that other tests were needed.

ShuntCheck is currently in use in 24 U.S. children’s hospitals and that number is expanding over time. Read the study here. More information on ShuntCheck can be found here.