Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2011-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Lumbar puncture
The participants randomly assigned to this arm will receive a lumbar puncture using standard procedures and equipment
No interventions assigned to this group
Lumbar puncture with the Compass device
The participants randomly assigned to this group will receive a lumbar puncture with the use of the Compass device.
Compass Lumbar Puncture Enhanced
Participants randomly assigned to this group will receive a lumbar puncture using the Compass device.
Interventions
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Compass Lumbar Puncture Enhanced
Participants randomly assigned to this group will receive a lumbar puncture using the Compass device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Life Sciences Development Fund
UNKNOWN
Seattle Children's Hospital
OTHER
Responsible Party
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Seattle Children's Hospital
Principal Investigators
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JUlie C. Brown, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital, Pediatric Emergency Department
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COMPASS13373
Identifier Type: -
Identifier Source: org_study_id
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