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COMPASS Device for Pediatric Spinal Tap Success
N/A
Waitlist Available
Led By JUlie C. Brown, MD, MPH
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Parent is able to read English or Spanish
Age 0 - 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 minute to 2 hours
Awards & highlights
Study Summary
This trial will test a new pressure transducer, the Compass Lumbar Puncture Enhanced, to see if it increases the success of lumbar punctures in the pediatric emergency department.
Who is the study for?
This trial is for children aged 0-18 who need a spinal tap and are at Seattle Children's Hospital. They must have a guardian who can read English or Spanish, and the procedure must be done by a provider trained to use the Compass device. It excludes foster children without guardians, those with lower spine deformities like spina bifida, or pregnant children.Check my eligibility
What is being tested?
The study tests if using the Compass Lumbar Puncture Enhanced—a new pressure transducer—improves success rates of lumbar punctures in kids by providing immediate feedback on cerebrospinal fluid pressure. Success includes obtaining fluid on first attempt, getting enough for standard tests, reducing blood contamination, and increasing provider satisfaction.See study design
What are the potential side effects?
There may not be direct side effects from using the Compass device itself; however, general risks associated with lumbar punctures include headache, back pain, bleeding around the spine or infection where the needle was inserted.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can read English or Spanish.
Select...
I am 18 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 minute to 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute to 2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lumbar puncture success
Secondary outcome measures
Obtain sufficient CSF fluid
Obtaining CSF fluid
Provider satisfaction
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lumbar puncture with the Compass deviceExperimental Treatment1 Intervention
The participants randomly assigned to this group will receive a lumbar puncture with the use of the Compass device.
Group II: Lumbar punctureActive Control1 Intervention
The participants randomly assigned to this arm will receive a lumbar puncture using standard procedures and equipment
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
301 Previous Clinical Trials
5,216,917 Total Patients Enrolled
Life Sciences Development FundUNKNOWN
JUlie C. Brown, MD, MPHPrincipal InvestigatorSeattle Children's Hospital, Pediatric Emergency Department
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a spine condition like spina bifida affecting lumbar puncture.I can read English or Spanish.I am 18 years old or younger.My healthcare provider is trained and agrees to use the Compass device during my procedure.I need a lumbar puncture within 24 hours of arriving at the emergency department.
Research Study Groups:
This trial has the following groups:- Group 1: Lumbar puncture
- Group 2: Lumbar puncture with the Compass device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial still accept enrollees?
"Clinicaltrials.gov reveals that this medical trial has ceased to acquire more patients, with its first post dated January 1st 2011 and the final update occurring on February 15th 2011. On the other hand, there are currently 743 other studies recruiting participants right now."
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