Evaluation of an MRI-compatible Vital Signs Sensor System
NCT ID: NCT03384849
Last Updated: 2018-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-01-03
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MRI patients
Up to 200 patients of different age, weight and sex, which undergo MRI examinations.
MRI examination
The part of the body that is being scanned and the time of the MRI examination are not relevant.
Interventions
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MRI examination
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Military Institute of Aviation Medicine
OTHER_GOV
Responsible Party
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Principal Investigators
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Łukasz Dziuda, DSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Military Institute of Aviation Medicine
Locations
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Military Institute of Aviation Medicine
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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OPTO-MRI_01/2017
Identifier Type: -
Identifier Source: org_study_id
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