Reha Drive: Capacitive Electrocardiography in Car Seat in Cardiological Patients

Cardiac Events Clinical Trial

— RehaDrivecECG  

Official title:

Capacitive Electrocardiography in the Driver`s Seat and Elevation of Vital Signs Via Camera During Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382926
• Other study ID #: CTC-A 14-053
• Status: Completed
• Phase: N/A
• First received: March 3, 2015
• Last updated: March 12, 2015
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

In this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.

Description:

Increasing number of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to their fitness of driving during cardiac rehabilitation. Little trial data are known, only a position paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience. For judgement and recommendations automotive monitoring via contactless sensors might be helpful. Therefore while "driving" in a simulator distinct heart circulation situations will be created. Vital signs will be measured via long term electrocardiography (ECG) in comparison to contactless capacitive ECG (cECG) measurements via embedded sensors in the car seat as well as heart rate and breathing rate measurements via camera.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery)

• rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

• dementia

• lack of language ability

• pregnancy

• implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Events

Intervention

Other:
• Capacitive ECG and contactless heart and breathing rate measurements via camera
During a 30 minute driving simulation cardiologic patients in rehabilitation undergo capacitive ECG measurements via sensors in the car seat as well as heart and breathing rate measurements via camera according to the Eulerian Magnification Method.

Locations

Country	Name	City	State
Germany	Clinic of Rehabilitation "An der Rosenquelle", Kurbrunnenstreet 5	Aachen	North Rhine Westphalia
Germany	University Hospital Aachen, Department of Cardiology, Angiology, Pneumology and Intensive Medicine	Aachen	North Rhine Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	RWTH Aachen Institute of Medical Information Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breathing rate via contactless camera	feasibility of breathing rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data	30 minutes	Yes
Primary	arrhythmia	feasibility of cECG data for example as arrhythmia, tachycardia in comparison to long term ECG data	30 minutes	Yes
Secondary	Heart rate via contactless camera	feasibility of heart rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data	30 minutes	Yes