4 Clinical Trials for Various Conditions
The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.
The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.
Objective: To evaluate pediatric emergency department provider lumbar puncture success with and without the Compass Lumbar Puncture Enhanced, a new pressure transducer, in order to determine: the proportion of lumbar punctures where a) any cerebrospinal fluid is obtained on the first attempt, b) any cerebrospinal fluid is obtained on any attempt, and c) sufficient cerebrospinal fluid is obtained for standard tests (culture, chemistries, cell count); the time to provider success in obtaining a) a drop of fluid from the needle, and b) opening pressure measurement; the proportion of successful lumbar punctures that contain blood; and provider satisfaction. Background: Lumbar punctures are necessary to diagnose meningitis, neurological diseases and some cancers. They are common pediatric emergency department procedures that frequently require repeated attempts or are only partially successful, with sufficient blood to limit interpretation. Measuring cerebrospinal fluid pressure during lumbar punctures is recommended but rarely done, due to limitations of current technology. Liquid column manometry is cumbersome, time-consuming and frequently impractical. Existing pressure transduction probes that connect via tubing to external monitors are not designed or recommended for lumbar punctures. The pressure is displayed on a monitor that is difficult to view during the LP procedure and they equilibrate too slowly to keep pace of pressure changes during LPs. The Compass Lumbar Puncture Enhanced is a new, inexpensive, disposable, medical device, specifically designed for use during LPs, that has the potential to increase lumbar punctures success and decrease blood contamination. It attaches to the spinal needle and displays both a numeric pressure value and a pressure waveform, allowing physicians to more readily identify the cerebrospinal fluid space and measure cerebrospinal fluid pressure. The device is small, easy to use, and readily incorporated into standard practice. The Compass Lumbar Puncture Enhanced uniquely provides immediate feedback about pressure that may allow physicians to more quickly and confidently identify the CSF space, and instantly determine cerebrospinal fluid pressure when the space is reached. The investigators believe the Compass Lumbar Puncture Enhanced will increase lumbar punctures success and decrease the proportion containing blood. It has the potential to become the standard of care and be used in every lumbar puncture procedure. This study is expected to demonstrate the clinical utility of the Compass Lumbar Puncture Enhanced to the medical community. Increased awareness of the Compass Lumbar Puncture Enhanced and a positive demonstration of the viability of the technology will help attract either the investment capital or the strategic partnership necessary to fully develop the market.
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?