Intracranial hypertension
Conditions
Interventions
Gold Standard:Reference medical device (Gold Standard) :
Name: Invasive Intracranial Pressure Monitoring
System Type: External Ventricular drainage (EVD) System or brain Parenchymal
Probe Requireme
Index test:Device Under Evaluation:
Name: Non-invasive Intracranial Pressure Monitor
Model: DNYL-ICP-I
Accessory: Disposable Intracranial Pressure Sensor (DNYL-IPS-I)
Manufacturer: Dongnuo Medical Tec
Sponsors
Tianjin Huanhu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and <= 80 years, regardless of gender. 2. Clear clinical diagnosis, with invasive intracranial pressure monitoring (EVD or parenchymal probe) already planned or performed. 3. Intact, flat, and infection-free skin at the intended sensor application site on the head, providing a clean area for adhesion no smaller than the sensor size (avoiding the brow ridge, hairline, and significant hair). 4. The subject or their legal guardian voluntarily participates in the trial and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are open wounds, severe edema, active infections, dermatitis, scars, pigmented nevi, or skull defects in the area to be pasted on the head (such as after decompressive craniectomy). 2. There are intracranial lesions such as superior sagittal sinus thrombosis and arteriovenous malformations that may seriously interfere with near-infrared light signal acquisition. 3. Known history of severe allergies to medical adhesives, silicone or polymer materials. 4. It is expected that magnetic resonance imaging (MRI) examination or high-frequency electric knife surgery will be required during the trial period. 5. Vital signs are extremely unstable, expected survival time is less than 12 hours, or researchers believe that participating in the trial would bring additional risks or be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement between non-invasive and invasive measurements (Bland-Altman analysis, 95% LoA);Correlation between non-invasive and invasive measurements (Pearson correlation coefficient);Error distribution (percentage of data points with absolute error <=5 mmHg and <=10 mmHg);Proportion of successful signal acquisition;Incidence rate of sensor-related skin irritation (grade II or higher); | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical adherence performance of the sensor (detachment rate, edge lifting);Ease of use of the monitoring system (host and sensor) by healthcare professionals; | — |
Countries
China
Contacts
Public ContactZhang Guobin
Tianjin Huanhu Hospital
Outcome results
None listed