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临床试验/NCT02368158
NCT02368158Unknown不适用

Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients in Rehabilitation and Acute Clinic and Contactless Determination of Vital Signs Via Camera

RWTH Aachen University4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
4
主要终点
Electrocardiography (ECG)

研究概览

简要总结

In this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.

详细描述

Increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. A policy paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.Therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while "driving" in a simulator and evaluated via Lane Change Test (LCT). Also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.Therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
  • rehabilitation in clinic "An der Rosenquelle"

排除标准

  • lack of language ability
  • pregnancy

结局指标

主要结局

Electrocardiography (ECG)

时间窗: 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

Breathing rate (BR)

时间窗: every 5 minutes for 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

Heart rate (HR)

时间窗: every 5 minutes for 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

Blood pressure

时间窗: every 5 minutes for 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

oxygen saturation

时间窗: 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

mean deviation of baseline lane

时间窗: 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

mean reaction time

时间窗: 30 minutes

determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test

次要结局

  • heart rate (HR)(every 5 minutes for 30 minutes)
  • Breathing rate(every 5 minutes for 30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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