S06.7
Conditions
Interventions
Group 1: Subjects suffering from acute traumatic brain injury will receive daily blinded measurements with non-invasive UltaEasy3LACG device during the stay in the ICU (up to 14 days). A confirmed dia
Sponsors
Sonovum GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. Male or female subjects aged = 18 years, experiencing acute traumatic brain injury, regardless of severity 2. ICP probe placed 3. Provide a signed and dated informed consent indicating that the subject/ legal representative has been informed of all pertinent aspects of the study and that all information has been understood, or procedure according to MDR Article 68. 4. Planned ICU stay of minimum of 3 days after enrollment Inclusion criteria for the measurement: 1. Null adjustment of the ICP probe and plausibility check of the ICP probe 2. Stable circulation
Exclusion criteria
Exclusion criteria: 1. Subjects below an age of 18 years 2. Craniectomy due to the current injury (except for placing an ICP probe) 3. Cochlear implant user 4. Having head injury which prevents from TTUS placement (UltraEasy 3LACG) 5. Head skull width <13 cm 6. Any illness or circumstance that could affect the study purpose in the opinion of the Investigator 7. Employee or direct relative of an employee of the investigational site, the CRO, or of the study Sponsor 8. Status of the subject as a prisoner or as lawfully kept in an institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of TTUS for classification of increased ICP Negative predictive value (NPV) of TTUS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoint(s): - Specificity of TTUS for classification of normal ICP - Correct classifications of ICP, classification result is not shown to clinical on-site personal since this is a blinded study - Curve displaying sensitivity and (1-specificity) of non-invasive TTUS measurements by increasing ICP thresholds - Youden-Index for TTUS - Positive predictive value (PPV) - GOSE disability rating scale after 6 months - Adjusted sensitivity via logistic regression including covariates Secondary safety endpoint(s): - Adverse events during TTUS and invasive ICP measurements - Vital signs Explorative endpoint: - Sensitivity of TTUS for classification of increased ICP using further internal information of the medical device. | — |
Countries
Germany
Contacts
Public ContactBernhard Meyer
Klinikum rechts der Isar der Technischen Universität München
Outcome results
None listed