Hydrocephalus
Conditions
Keywords
Intracranial Pressure
Brief summary
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation. The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.
Detailed description
Participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (\>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. Participants will be recruited when they present to hospital requiring a shunt placement (or revision). At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.
Interventions
DEVICEKitea ICP Sensor
Kitea ICP Sensor placed in brain during shunt surgery.
Sponsors
University of Auckland, New Zealand
Health Research Council, New Zealand
Auckland City Hospital
Kitea Health Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery. * Adults: Age \> 16 years; Children: Age \>1 and \<15
Exclusion criteria
* Adults: Unable to give informed consent * Paediatric: Failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent. * Cortical mantle \< 20 mm * Neurologic or other condition that would prevent compliance with protocol * Terminal illness with expected survival \< 1 year * Unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period) * Underlying medical condition that would make the participant more prone to surgical infections * Other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices * Participants with conditions likely to require radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery | 3 months | The primary end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 3 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery | 6 months | The secondary safety end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 6 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal. |
| Recruitment rate | Through study completion, an average of 1 year | Proportion of all eligible participants who are enrolled over the study duration. |
| Data completeness of home ICP recordings using the Kitea ICP system. | 3 months | Wireless home ICP monitoring will be considered successful if 90% of the attempted ICP measures are able to be obtained. |
| Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System. | 3 months | As part of the protocol participants will be asked to make daily ICP measurements using the Kieta ICP system for the first 2 weeks after surgery and then make measurements at least every second day for the remainder of the 3 months. A participant survey at 3 months will collect participant feedback on the perceived burden of making those measurements. |
Countries
New Zealand
Contacts
PRINCIPAL_INVESTIGATORSarah-Jane Guild, PhD
The University of Auckland
Outcome results
None listed