Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials

Overview

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

• Device Intellidrop 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 bo
• Device Intellidrop Automated CSF Drainage System
  Participants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that provides continuous intracranial pressure monitoring and automated control of CSF removal. It is programmed to withdraw small frequent volumes of CSF within predefined safety limits reducing the need for manual stopcock adjustments and minimizing human error. It is designed to improve workflow efficiency, enhance patient mobility, and evaluate the device;s feasibility, performance a

Primary outcome measures

• Feasibility [Time frame: FIM scores will be obtained on a daily basis during month 3 - 5.]
• Acceptability [Time frame: from enrollment to the end of three months or until 10 subjects have been enrolled]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• UT Southwestern Medical Center — Dallas

Publications

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459

Identifiers

NCT: NCT07494812 · STU20260216

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗