A Randomized Clinical Trial of Pediatric Lumbar Puncture Success Using The Compass, a Compact Quantitative Pressure Transducer

Focus: 

To test if a pressure transducing device increases the success of lumbar puncture

Anticipated Impact: 

Greater success in lumbar punctures

Abstract: 

Lumbar punctures (LPs) to extract a sample of cerebrospinal fluid (CSF) 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. Measuring CSF pressure during LP is recommended but rarely done, due to limitations of current technology. The Compass is a new, inexpensive, and disposable medical device specifically designed for use during LPs. A randomized clinical trial will compare the Compass against standard care and document time to successfully collect sample, physician satisfaction, and complications. Positive results will improve patient care, decrease costs due to inconclusive results, and help attract investment capital or strategic partnerships to develop the market for the Compass. Mirador Biomedical, a start-up medical device company, is collaborating.

Collaborating organizations: Mirador Biomedical, Inc.

Lumbar Puncture

Grant Update

Principal Investigator:
Julie Brown
Grantee Organization:
Seattle Children's Research Institute
Grant Title:
A Randomized Clinical Trial of Pediatric Lumbar Puncture Success Using The Compass, a Compact Quantitative Pressure Transducer
Grant Cohort and Year:
2010 First Round Commercialization (03)
Grant Period:
09/08/2010 - 09/07/2013 (Completed)
Grant Amount:
$147,033
To date, study enrollment is complete and 61 patients have been enrolled, with 60 patients completing all study procedures. Data analysis is actively underway. Unadjusted chi2 analysis results indicate that using the Compass during the needle advancement portion of the LP procedure resulted in no significant increase in success in obtaining CSF on any attempt; obtaining CSF on first attempt; or obtaining CSF for cell count and culture when using the Compass during the LP, compared to standard LP technique. There was no reduction in number of attempts. When adjusting for patient age, race, gender, and provider experience in generalized linear regression models, there is similarly no significant increase in obtaining CSF on any attempt; obtaining CSF on first attempt; or obtaining CSF for cell count culture. We will submit an abstract for the 2014 Pediatric Academic Societies meeting which includes these results. Further analysis and presentation of these results is ongoing. It is worth noting that while the Compass device is not currently being used at our hospital DURING needle insertion, as a means of determining CSF space entry, after training on the device, our providers preferred it to water column manometry for measuring CSF pressure AFTER CSF was flowing. For this reason, the Compass device is now in routine use in our Emergency Department as well as many other areas throughout the hospital.

Impact in Washington

Location of LSDF Grantee
Locations of Collaborations/Areas of Impact
Seattle

Legislative Districts:
11, 34, 36, 37, 43, 46

Health Impacts

Lumbar Puncture