Evaluation of an MRI-compatible Vital Signs Sensor System

Anxiety Clinical Trial

— OPTO-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384849
• Other study ID #: OPTO-MRI_01/2017
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Claustrophobia
• Hyperventilation
• Phobic Disorders
• Stress

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