Clinical Trial of Noninvasive Intracranial Pressure Measurement

JRCT ID: jRCTs032200074

Registered date:29/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: disease in neurosurgical field
• Date of first enrollment: 29/07/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): External auditory canal pressure is recorded by the original headset placed on the external auditory canal.

Outcome(s)

• Primary Outcome: This research is for the refinement of the analogical program in the non-invasive intracranial pressure apparatus.
• Secondary Outcome: not arranged.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patient who have a disease in neurosurgical field
2. age: over 1 year
3. sex: not concern
4. informed consent from patient him/herself or legal representative when the patient is under 20 years or loss of consciousness.
5. patient of increased ICP state
6. patient of intact middle and external auditory canal
7. patient who had a radiological examination just before examination
8. patient who can keep resting state over 30 minutes.
9. patient who is safe against occlusion of a ventricular drainage over 30 minutes.

Exclude criteria

1. past history: ottitis
2. past history: pyramidal bone fracture
3. severe facial and head laceration
4. patient who is considered to be inappropriate for inclusion to this research

Related Information

• Primary Sponsor: Goto Tetsuya
• Source(s) of Monetary Support: ICHIKAWA ELECTRIC CO.,LTD.,Grants-in-Aid for Scientific Research