Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
|ClinicalTrials.gov Identifier: NCT02773862|
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries Intracranial Hypertension||Device: HS-1000||Not Applicable|
In this pilot study, the investigators will prospectively collect relevant clinical data on 15 TBI patients with an inserted invasive ICP monitor. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's ICP monitor. Subjects who meet the study's inclusion and exclusion criteria will be enrolled in the study. Family members will be asked for consent. The patient's clinical condition will be recorded in a case record form (CRF).
Once the patient is inclined with his upper body 30 degrees to the bed and the invasive ICP monitor displays the pressure values, the clinical procedure can begin. Once the HeadSense's monitor is calibrated it is connected to the front end that is placed on the patient's ears. Each recording session will be ½-48 hours long, depending on the patient's clinical condition. In case the ICP monitor is still inserted to the patient's brain in the following day, recording sessions will continue until the ICP monitor is removed.
After the study, the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred, and the family or advocate of the patient will be informed. In case of clinical relevant adverse event, appropriate clinical action will be taken.
As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.
Once the data collection is done, results will be analyzed by comparing ICP readings from both devices. The end point of the study is to collect at least half an hour of ICP monitoring for each participant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: HS-1000 recording
ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition.
- Number of ICP values obtained by the HS device that correlate to ICP using current standards [ Time Frame: 30 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773862
|St. Elisabeth Ziekenhuis|
|Principal Investigator:||Guus Schoonman, MD, PhD||St. Elisabeth/Tweesteden Hospital Tilburg|