NPH (Normal Pressure Hydrocephalus)
Conditions
Keywords
UPGRADE, Cerebrospinal fluid buildup (CSF buildup)
Brief summary
The intellidrop device is an FDA-approved system that automates safe, small volume of cerebral spinal fluid drainage with continuous pressure monitoring, reducing nursing workload and human error while improving patient mobility and comfort
Detailed description
The intellidrop (BrainSpace, Inc) was approved by the Food and Drug Administration (FDA) for use in automating CSF drainage while providing continuous intracranial pressure (ICP) monitoring. Control parameters can be programmed for requent removal of small volumes of fluid contingent on pressure remaining in target range, and with guardrails on volume drained over a range of timespans. This reduces the frequency and duration of nursing attention to managing the stopcock every four hours as in the current design and may reduce risk of human error. The compact and mobile design allows for more freedom for patient mobility, and importantly for patient satisfaction, there is no longer a need for the patient to lay supine for one out of every four hours because substantial (20mls) volumes of CSF are no longer removed.
Interventions
DEVICEIntellidrop Automated CSF Drainage System
Participants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that monitors intracranial or spinal pressure and manages external drainage of cerebrospinal fluid and other body fluids to a user selected pressure target or volume target. Its closed loop, gravity-based drainage ensures natural flow, while offering position-agnostic precision control to achieve an hourly target volume. It connects to the distal end of the lumbar catheter outside the body and replaces the drainage collection device and manual nursing effort.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This study uses a single-group interventional design in which all participants undergo lumbar drain trials using the Intellidrop device (BrainSpace) automated CSF drainage system. The Intellidrop evaluates feasibility, workflow efficiency, and safety by observing system performance and patient responses without comparison to a control group. The lumbar drain will be connected to the Intellidrop device and set to drain 5 mL per hour. The entire period will be four days, the drain will be removed on the 4th day.
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* All patients will be adults aged 60 years or older with suspected iNPH who are being admitted to the hospital for the purpose of an LDT specifically to evaluate for benefit from shunt placement.
Exclusion criteria
* Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | FIM scores will be obtained on a daily basis during month 3 - 5. | The feasibility of the intervention will be measured using the feasibility of the intervention measure (FIM). The FIM is a four item instrument that evaluates feasibility. The four scores are sumed and divided by 5 to provide a final score ranging from 0 to 1.0 with higher score indicating greater feasibility. |
| Acceptability | from enrollment to the end of three months or until 10 subjects have been enrolled | The acceptability of the intervention will be measured using the acceptablity of the intervention measure (AIM). The AIM is a four item instrument that evaluates feasibility. Similarly to the FIM score, the four scores are sumed and divided by 5 to provide a final score ranging from 0 to 1.0 with higher score indicating greater acceptablity. |
Countries
United States
Contacts
CONTACTPadraig O'Suilleabhain, M.D.
CONTACTMaria Denbow, CCRP
STUDY_DIRECTORDaiWai Olson, PhD, RN, CCRN, FNCS
University of Texas
Outcome results
None listed