Pediatric Lumbar Puncture Success Using the COMPASS

Status unconfirmed · Not applicable

Conditions studied: Lumbar Puncture

In brief

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.

Key facts

Study ID

NCT01285531

Run by

Seattle Children's Hospital

People needed

60

Starts

2011-01-01

Last updated by the study team

2011-02-17

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 0 - 18 years old
• Patient was in the Seattle Children's Hospital (SCH) Emergency Department (ED)within 24 hours
• Patient requires lumbar puncture (can be performed in the ED or inpatient, within 24 hours of arrival to the ED)
• Parent is able to read English or Spanish
• A provider who is trained in the use of the Compass device is willing and able to use it during the LP

You may not qualify if…

• Child is a foster child or ward of the state or is unaccompanied by their legal guardian
• Child has a lower spine deformity, such as spina bifida, that would impact lP success
• The child is pregnant, by verbal report or clinically available test results

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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