Validation of Non-invasive Absolute Intracranial Pressure Monitoring

NCT03227354 | Unknown

• 1 other identifier: aICP Validation 2
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective of this study is to assess the accuracy and precision of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive, measurement. Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous, non-invasive measurement and standard, invasive,measurement

Conditions

Intracranial Pressure Increase; Traumatic Brain Injury

Keywords

Medical Device

Outcome Measures

Primary Outcomes (1)

• Absolute intracranial pressure

  absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method

  35 minutes per measurement

Other Outcomes (1)

• Safety outcome

  during measurements

Interventions

Vittamed 205 DEVICE

non-invasive Intracranial Pressure measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, age ≥ 18 years, after Traumatic Brain Injury, Intrcranial Hemorrhage, secondary edema after stroke or SAH

You may qualify if:

• Adult patients, age ≥ 18 years, admitted after TBI, ICH, secondary edema after stroke or SAH at the Departments of Neurosurgery or Neurology, Kantonsspital Aarau, Switzerland.
• Patients under sedation and ICP monitoring
• Informed consent obtained from the legally authorized representative prior initiation of the measurements.

You may not qualify if:

• Age \< 18 years at study entry.
• Patients with wounds, scars including the front orbital region.
• Perforating or penetrating mechanism of TBI
• Patients with orbital injury or abnormal blood flow in both Ophthalmic Arteries
• Patients with previous retina surgery
• Patients with previous cataract surgery
• Patients with any known ocular condition that may be worsened by sustained eye pressure in the opinion of the subject's ophthalmologist
• Patients with radiological signs of calcification or atheromatose plaques in the internal carotid artery detected by CT or angiography (performed prior and independently of the study)

Sponsors & Collaborators

• Kienzler Jenny: lead
• Swiss National Science Foundation: collaborator

MeSH Terms

Conditions

Intracranial Hypertension; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• jenny kienzler

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Kienzler

CONTACT

+41 62 838 58 72; jenny.kienzler@ksa.ch

javier Fandino

CONTACT

+41 62 838 66 90; javier.fandino@kas.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share