Evaluation of an MRI-compatible Vital Signs Sensor System

Study Overview
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Brief Summary
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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 and/or 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
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The main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve and/or 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 patient's 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 patient's 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 and/or 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.

Official Title
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Clinical Evaluation of a Fiber-optic Sensor System for Monitoring Respiration Activity and Heart Work During MRI Examinations

Conditions
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Anxiety, Claustrophobia, Hyperventilation, Stress

Intervention / Treatment
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* Diagnostic Test: MRI examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRI patients Exclusion Criteria: Same as in MRI procedures
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI patients<br>Up to 200 patients of different age, weight and sex, which undergo MRI examinations. | Diagnostic Test: MRI examination<br>* The part of the body that is being scanned and the time of the MRI examination are not relevant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical signal | Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR | Respiration rate in respirations per minute | 60 minutes | 
| HR | Heart rate in beats per minute | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber-optic sensor system, Magnetic resonance imaging, Medical monitoring, Physiological parameters