Suspected CSF Shunt Obstruction
Conditions
Keywords
hydrocephalus, CSF shunt, shunt malfunction, shunt obstruction, ShuntCheck, ShuntCheck-Micro-Pumper
Brief summary
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Interventions
DEVICEShuntCheck-Micro-Pumper (SCMP)
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow downstream of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
DEVICEImaging
Imaging of ventricle size
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
NeuroDx Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Months to 29 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females, older than 35 months and less than 20 years of age. 2. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required. 3. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle. 4. Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition 5. Will be available for follow-up for up to 7 days
Exclusion criteria
1. Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board. 2. Presence of multiple shunts or known non-functioning shunts crossing the clavicle. 3. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination. 4. SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order. 5. Presence of an interfering open wound or edema over the shunt. 6. Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable. 7. Any other condition that would preclude or bias the results of the study according to the judgment of the investigator. 8. Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy compared with clinical outcomes | 7 days | SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. |
| Positive Predictive Value (PPV) | 7 days | Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone. |
| Negative Predictive Value (NPV) | 7 days | Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone. |
| Safety | 1 day | To determine if any adverse events were caused by the device or procedure while using the study device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rule Out for Low Risk Cases | 7 days | To demonstrate that SCMP plus Physician's judgment is comparable to Physician's judgment plus imaging in ruling out shunt malfunction in patients judged to be Unlikely to require shunt surgery |
| Increased PPV and NPV for Uncertain Cases | 7 days | To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation. |
Countries
United States
Contacts
Primary ContactJoseph R Madsen, MD
Backup ContactEun-Hyoung Park
Outcome results
None listed