NCT02030366

Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury

A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in patients who can benefit from evacuation procedures can lead to worse brain injury, worse outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In this study we will examine the feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for pupillary responses using this device.

Detailed description

To examine the feasibility of using the multifocal chromatic pupillometer for monitoring TBI, the pupillary response to multifocal chromatic stimuli will be assessed in 20 healthy subjects and 20 ICP-monitored severe TBI patients. The portable pupillometer will be tested in 20 healthy volunteers. Their pupillary responses will be measured 3 times/day for 1 week. Pupillary response of 20 severe TBI patients will be evaluated as detailed below at the following time points: 1. At admittance to ICU, prior to insertion of ICP and CT scan 2. Prior to CT scans that are routinely performed at day 3 and 7 post injury 3. Routinely at the beginning of every medical personnel shift for 7 days (3 times a day). 4. With every change in ICP(more than 5 mmHg for more then 15 min) Data will be recorded and analyzed.

Conditions

• Traumatic Brain Injury (TBI) Patients

Timeline

• Start date: 2015-10-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2014-01-08
• Last updated: 2024-04-25

Locations

1 site across 1 country: Israel