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Evaluation of an MRI-compatible Vital Signs Sensor System

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03384849
Acronym
OPTO-MRI
Enrollment
200
Registered
2017-12-27
Start date
2017-01-03
Completion date
2019-07-31
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Claustrophobia, Hyperventilation, Stress

Keywords

Fiber-optic sensor system, Magnetic resonance imaging, Medical monitoring, Physiological parameters

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 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

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.

Interventions

DIAGNOSTIC_TESTMRI examination

The part of the body that is being scanned and the time of the MRI examination are not relevant.

Sponsors

Military Institute of Aviation Medicine
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* MRI patients

Exclusion criteria

* Same as in MRI procedures

Design outcomes

Primary

MeasureTime frameDescription
Optical signal60 minutesInstantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram

Secondary

MeasureTime frameDescription
RR60 minutesRespiration rate in respirations per minute
HR60 minutesHeart rate in beats per minute

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORŁukasz Dziuda, DSc, PhD

Military Institute of Aviation Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026