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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03384849
Other study ID # OPTO-MRI_01/2017
Secondary ID
Status Recruiting
Phase N/A
First received December 20, 2017
Last updated January 4, 2018
Start date January 3, 2017
Est. completion date September 30, 2018

Study information

Verified date December 2017
Source Military Institute of Aviation Medicine
Contact Lukasz Dziuda, DSc, PhD
Phone +48 261-852-621
Email ldziuda@wiml.waw.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- MRI patients

Exclusion Criteria:

- Same as in MRI procedures

Study Design


Intervention

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

Locations

Country Name City State
Poland Military Institute of Aviation Medicine Warszawa

Sponsors (1)

Lead Sponsor Collaborator
Military Institute of Aviation Medicine

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other RR_1 Respiration rate at the beginning of the MRI scanning in respirations per minute 2 minutes
Other RR_2 Respiration rate at the end of the MRI scanning in respirations per minute 2 minutes
Other HR_1 Heart rate at the beginning of the MRI scanning in beats per minute 2 minutes
Other HR_2 Heart rate at the end of the MRI scanning in beats per minute 2 minutes
Other STAI X-1_1 STAI X-1 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety). 1 minute
Other STAI X-1_2 STAI X-1 scores completed after the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety). 1 minute
Other STAI X-2 STAI X-2 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety). 1 minute
Primary Optical signal Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram 60 minutes
Secondary RR Respiration rate in respirations per minute 60 minutes
Secondary HR Heart rate in beats per minute 60 minutes
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