Lumbar PunctureNCT01285531
Pediatric Lumbar Puncture Success Using the COMPASS
A study testing Compass Lumbar Puncture Enhanced in people with Lumbar Puncture, run by Seattle Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- Compass Lumbar Puncture Enhanced
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Julie C. Brown, MD, MPH, 206-987-4016, julie.brown@seattlechildrens.org
Daniel P. Osincup, BA, 206-987-2939, daniel.osincup@seattlechildrens.org
About this study
Official title: 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 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.
Read the detailed description
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.
- Conditions
- Lumbar Puncture
- Being tested
- Compass Lumbar Puncture Enhanced
- Keywords
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compass Lumbar Puncture EnhancedDevice
Also called compass
Participants randomly assigned to this group will receive a lumbar puncture using the Compass device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Compass Lumbar Puncture Enhanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 minute to 2 hours
Secondary outcomes (6)
Obtaining CSF fluid
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
Measured: 1 minute to 2 hours
Obtain sufficient CSF fluid
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 sufficient CSF is obtained for standard tests (culture, chemistries and cell count) on any attempt
Measured: 1 minute to 2 hours
Successful traumatic LPs (contaminated with blood)
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 successful LPs that are traumatic (contaminated with blood)
Measured: 1 minute to 2 hours
Time to fluid
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 time to provider success in obtaining a drop of fluid from the needle
Measured: 1 minute to 2 hours
Time to LP opening pressure
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 time to provider success in obtaining opening pressure measurement
Measured: 1 minute to 2 hours
Provider satisfaction
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 provider satisfaction with the procedure +/- device.
Measured: 1 minute to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar PunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Life Sciences Development Fund
- Investigators
- JUlie C. Brown, MD, MPH, Principal investigator, Seattle Children's Hospital, Pediatric Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285531
- Sponsor's protocol ID
- COMPASS13373
- Status last verified
- Feb 2011
- First submitted
- 9 Dec 2010
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Review Board Application #13373, Entitled "A Randomized Clinical Trial of Pediatric Lumbar Puncture Success Using The Compass, a Compact Quantitative Pressure Transducer
- ClinicalTrials.gov ID
- NCT01285531
- Acronym / sponsor ID
- COMPASS13373
- Conditions
- Lumbar Puncture
- Keywords
- 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.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Life Sciences Development Fund
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Compass Lumbar Puncture EnhancedThe participants randomly assigned to this group will receive a lumbar puncture with the use of the Compass device. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compass Lumbar Puncture EnhancedAlso: compassParticipants randomly assigned to this group will receive a lumbar puncture using the Compass device. | Device | Lumbar puncture with the Compass device |
Primary outcome
Lumbar puncture success
Time frame: 1 minute to 2 hours
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
6 secondary outcomes
Obtaining CSF fluid
Time frame: 1 minute to 2 hours
Obtain sufficient CSF fluid
Time frame: 1 minute to 2 hours
Successful traumatic LPs (contaminated with blood)
Time frame: 1 minute to 2 hours
Time to fluid
Time frame: 1 minute to 2 hours
Time to LP opening pressure
Time frame: 1 minute to 2 hours
Provider satisfaction
Time frame: 1 minute to 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUlie C. Brown, MD, MPH principal investigator
Seattle Children's Hospital, Pediatric Emergency Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compass Lumbar Puncture Enhanced in people with Lumbar Puncture, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie C Brown, MD, MPH (206-987-4016, julie.brown@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar puncture success (time frame: 1 minute to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.