on-invasive measurement of the intracranial pressure with the HeadSense HS-1000 compared to the conventional invasive measurement

• Conditions: G91.2; Benign intracranial hypertension; G93.2; Normal-pressure hydrocephalus

• Registration Number: DRKS00011211
• Lead Sponsor: Abteilung Neurochirurgie Bundeswehrkrankenhaus Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-18
• Study Completion: 2018-03-15
• Results First Posted: 2022-12-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

invasive ICP-Device

Exclusion Criteria

- Unconsciousness
- Lack of capacity for consent
- Pregnancy
- Lactation period
- Infection of the auditory canal or ear
- Latex allergy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of the study is to determine the precision of the Headsense device compared to the invasive measurement of ICP as the <br>actual standard.<br><br>To do this the ICP is measured simultaneously by the Headsense device and an invasive probe. Then the data gets transferred in a software <br>and gets evaluated.<br>

Secondary Outcome Measures

Name	Time	Method
Further objectives are to evaluate handling and comfort of the device and the procedure of measurement. After the measurement, patient and user get a questionnaire to assess these characteristics.<br>