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Institutional Review Board Application #13373, Entitled "A Randomized Clinical Trial of Pediatric Lumbar Puncture Success Using The Compass, a Compact Quantitative Pressure Transducer


N/A
N/A
18 Years
Open (Enrolling)
Both
Lumbar Puncture

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Trial Information

Institutional Review Board Application #13373, Entitled "A Randomized Clinical Trial of Pediatric Lumbar Puncture Success Using The Compass, a Compact Quantitative Pressure Transducer


Objective: To evaluate pediatric emergency department (ED) 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 (LPs) where a) any cerebrospinal fluid
(CSF) is obtained on the first attempt, b) any CSF is obtained on any attempt, and c)
sufficient CSF 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 a lumbar puncture 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 LPs. The pressure is displayed on a monitor that is difficult to view during
the lumbar puncture procedure and they equilibrate too slowly to keep pace of pressure
changes during lumbar puncture. The Compass Lumbar Puncture Enhanced is a new, inexpensive,
disposable, medical device, specifically designed for use during lumbar punctures, that has
the potential to increase lumbar puncture 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.

Methods: This randomized clinical trial will test adding the Compass Lumbar Puncture
Enhanced vs. standard care in 60 children 0-16 years old who are receiving a lumbar puncture
in the Seattle Children's Hospital Emergency Department. We will test the Compass Lumbar
Puncture Enhanced against standard care in 60 children receiving lumbar puncture, comparing
success, pressures obtaining, time to success, complications (e.g. >200 red blood cells/mm3)
and provider satisfaction. Results will be compared with chi-squared tests, regressions,
Kaplan-Meier and logrank tests. We expect improved success, decreased time to success and
complications and high provider satisfaction.

Impact: Currently, one third of lumbar punctures require multiple attempts, 7-20% contain
blood that limits interpretation, and 6% are unsuccessful. This results in unnecessary
hospitalizations, increased hospital days, increased antibiotic use and increased numbers of
repeat procedures. The Compass Lumbar Puncture Enhanced uniquely provides immediate feedback
about pressure that will allow physicians to more quickly and confidently identify the
cerebrospinal fluid space, and instantly determine cerebrospinal fluid pressure when the
space is reached. We believe the Compass Lumbar Puncture Enhanced will increase lumbar
puncture 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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Lumbar puncture success

Outcome Description:

Time to lumbar puncture success. In pediatric patients receiving emergency department care, we aim to evaluate pediatric ED provider LP success with and without the Compass, in order to determine the proportion of LPs where any CSF is obtained on any attempt

Outcome Time Frame:

1 minute to 2 hours

Safety Issue:

No

Principal Investigator

JUlie C. Brown, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Children's Hospital, Pediatric Emergency Department

Authority:

United States: Institutional Review Board

Study ID:

COMPASS13373

NCT ID:

NCT01285531

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Lumbar Puncture
  • lumbar puncture
  • Compass
  • pressure transducer
  • manometry
  • The focus of the study is to improve lumbar puncture(LP)success, reduce the number of LP attempts, reduce the number of traumatic attempts.

Name

Location

Seattle Children's HospitalSeattle, Washington  98105