Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage

Traumatic Brain Injury (TBI) Clinical Trial

Official title:

Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172703
• Other study ID #: aICP_CH_TBI_SAH
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: July 7, 2015
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.

Aim:

The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.

Methods:

The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, age = 18 years, admitted after TBI or SAH at the Neurosurgical Department, Kantonsspital Aarau, Switzerland.

• Patients under sedation and ICP monitoring

• Informed consent will be obtained from the relatives prior to initiation of the measurements.

• study inclusion/informed consent from relatives possible between hour 24 to 72 after admission to the hospital

Exclusion Criteria:

• 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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage (SAH)
• Traumatic Brain Injury (TBI)

Intervention

Device:
• Non-invasive ICP measurement device
The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania. The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau, Department of Neurosurgery	Aarau	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Javier Fandino, MD	Kaunas University of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury)	Physiological parameters of TBI or SAH patients of primary interest are simultaneously measured paired non-invasive and invasive ICP values.; New measurement is only initiated if ICP changes for more than 4mmHg in comparison to proceeding measurement.	Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe)	No