EVD Drainage Data and Intracranial Pressure (ICP) Measurements

ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-21
SponsorBaylor College of Medicine

About this trial

Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now.

FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with one or more existing external ventricular drains (EVDs).

Disqualifiers

Patients with no external ventricular drains (EVDs).

Trial design

Design model

Parallel

Treatments tested in this trial

  • FlowSense

    Device

    Patients will have one or more existing external ventricular drains (EVDs). Phase B patients will additionally have an accessible (shaved) region of skin \>3 cm x 3 cm overlaying the EVD tubing. Clinical data to be collected include: 1) total drainage volume1 over the 20-minute measurement period; 2) handheld ultrasound measurement of skin thickness2 over the EVD; and 3) an ICP waveform from a standard-of-care transducer, 4) dimensions (inner diameter and outer diameter) of tunneled catheter. Single patients may be measured multiple times during their admission; each measurement will be considered independent for analysis.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Phase A:No intervention 0 interventions
Group B: Phase BOther 1 intervention

Trial outcomes

Primary outcomes

1

Exploratory outcome

Number of participants with accurate cerebrospinal flow rate measurements (measured through the FlowSense device), EVD drainage, intracranial pressure measurements. This will be measured using a video camera. We will see the changes in flow for every 20 minutes in the recording. However, this project is not intended to be statistically powered

Time frame
1 year

Secondary outcomes

1

Suitability

Number of times the video recording works properly by visually playing back the videos.

Time frame
1 year

Other outcomes

Sponsors and contacts

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