Pediatric Lumbar Puncture
Conditions
Brief summary
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.
Interventions
DEVICEInjeq IQ-Needle
Injeq IQ-Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.
Sponsors
Injeq Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No
Inclusion criteria
* Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample. * Consent from the parents
Exclusion criteria
* Being a high risk patient (as determined by the investigator) * Any contraindication to a common lumbar puncture apply also in the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form | During lumbar puncture | Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect CSF, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the lumbar puncture and were the detections true or false detections. |
Countries
Finland
Outcome results
None listed