NCT01285531

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

December 9, 2010

Last Update Submit

February 15, 2011

Conditions

Lumbar Puncture

Keywords

lumbar punctureCompasspressure transducermanometryThe focus of the study is to improve lumbar puncture(LP)success, reduce the number of LP attempts, reduce the number of traumatic attempts.

Outcome Measures

Primary Outcomes (1)

  • Lumbar puncture success

    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

    1 minute to 2 hours

Secondary Outcomes (6)

  • Obtaining CSF fluid

    1 minute to 2 hours

  • Obtain sufficient CSF fluid

    1 minute to 2 hours

  • Successful traumatic LPs (contaminated with blood)

    1 minute to 2 hours

  • Time to fluid

    1 minute to 2 hours

  • Time to LP opening pressure

    1 minute to 2 hours

  • +1 more secondary outcomes

Study Arms (2)

Lumbar puncture

NO INTERVENTION

The participants randomly assigned to this arm will receive a lumbar puncture using standard procedures and equipment

Lumbar puncture with the Compass device

EXPERIMENTAL

The participants randomly assigned to this group will receive a lumbar puncture with the use of the Compass device.

Device: Compass Lumbar Puncture Enhanced

Interventions

Compass Lumbar Puncture EnhancedDEVICE

Participants randomly assigned to this group will receive a lumbar puncture using the Compass device.

Also known as: compass
Lumbar puncture with the Compass device

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Study Officials

  • JUlie C. Brown, MD, MPH

    Seattle Children's Hospital, Pediatric Emergency Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie C Brown, MD, MPH

CONTACT

206-987-4016julie.brown@seattlechildrens.org

Daniel P. Osincup, BA

CONTACT

206-987-2939daniel.osincup@seattlechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2010

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

US(1)