Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03384849
Status:
UNKNOWN
Last Update Posted:
2018-01-05
First Post:
2017-12-20
Brief Title:
Evaluation of an MRI-compatible Vital Signs Sensor System
Sponsor:
Military Institute of Aviation Medicine
Organization:
Military Institute of Aviation Medicine
Study Overview
Official Title:
Clinical Evaluation of a Fiber-optic Sensor System for Monitoring Respiration Activity and Heart Work During MRI Examinations
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
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:
OPTO-MRI
Brief Summary:
This study is to determine the possibility of assessing the level of anxiety in MRI patients by means of the respiration rate RR and heart rate HR indicators acquired by a fiber-optic sensor system The mean RR andor HR values recorded at the beginning and the end of an MRI scanning will be referred to the State Trait Anxiety Inventory STAI scores completed before and after the MRI scanning respectively
Detailed Description:
The main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve andor ballistocardiographic BCG signal acquired from MRI patients using a fiber-optic sensor system In many patients the MRI examination causes enormous stress due to limited space in the scanner isolation during the examination and high noise levels Usually anxiety or stress triggers an increase in respiration rate RR leading to hyperventilation in extreme cases There are also frequent cases of disturbances in heart rate HR Thus the symptoms of claustrophobia can be detected by monitoring respiration activity and heart work
The fiber-optic sensor system consists of a sensor mat an interrogator and a personal computer PC and records respiratory and BCG signals in patients during MRI The metal-free sensor mat is placed under the patients back does not pose a threat to the patient and has no influence over the quality of imaging The interrogation module detects the optical signal including vital signs and the PC with software developed for signal processing and visualization enable the MRI operator to monitor patients RR and HR
Up to 200 MRI patients in different age weight and gender will be participated in the study They will be asked to complete the State Trait Anxiety Inventory STAI questionnaire in order to estimate anxiety level before and after the MRI scanning Relations between the STAI X-1 scores and the mean RR andor HR values recorded at the beginning and the end of the MRI scanning will be analyzed using descriptive statistic methods The research scheme includes also the collection of the STAI X-2 scores before the MRI scanning Finally the values of the physiological parameters which may indicate a dangerous level of anxiety will be determined Positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine MRI procedures
The fiber-optic sensor system consists of a sensor mat an interrogator and a personal computer PC and records respiratory and BCG signals in patients during MRI The metal-free sensor mat is placed under the patients back does not pose a threat to the patient and has no influence over the quality of imaging The interrogation module detects the optical signal including vital signs and the PC with software developed for signal processing and visualization enable the MRI operator to monitor patients RR and HR
Up to 200 MRI patients in different age weight and gender will be participated in the study They will be asked to complete the State Trait Anxiety Inventory STAI questionnaire in order to estimate anxiety level before and after the MRI scanning Relations between the STAI X-1 scores and the mean RR andor HR values recorded at the beginning and the end of the MRI scanning will be analyzed using descriptive statistic methods The research scheme includes also the collection of the STAI X-2 scores before the MRI scanning Finally the values of the physiological parameters which may indicate a dangerous level of anxiety will be determined Positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine MRI procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None