Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-27 @ 5:41 PM
Study NCT ID:
NCT02030366
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2014-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: