- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02832518
Analyse Cardio-respiratory Patterns in Order to Early Detect the Clinical Complications in the Hemodialysis Patients
Using Contact Free Sensor to Analyse Cardio-respiratory Patterns in Order to Early Detect the Clinical Complications in the Hemodialysis Patients.
The incidence and prevalence of dialysis in Taiwan remains higher as compared to past several years. The number of dialysis reported about 6-7 million people each year and the 2014 full-year cost estimation was about 330 million NTDs. According to age-standardized population statistics in 1995, the number of dialysis per million population in 2006 year were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent recorded.
EarlySense system is certified by TFDA, FDA and many other countries, which consists of mainly two parts. One for the sensing element, which placed under the mattress and the other one is AC-powered display panel bed. This system has the ability to monitor the patients physiological functions just be in contact via bed. When the patient laid on bed, the sensor which is placed under the bed would detects heart rate, breathing rate and activity level as well as other physiological signals. The system is also able to distinguish between patients in bed and out of bed during the operation to save the patient's records and information (including heart rate, respiratory rate and level of activity, and may render trends). The system is also have capability for real-time data transmission information which includes a warning to the nurses' station or other monitoring center of the screen by providing real-time information to nurse.
In this research project, we will use EarlySense equipment for continuous monitoring the dialysis patient's physiological data along with clinical data such as A. acute complications such as rapid changes in blood pressure, respiratory rate, movements of patients and Nausea or vomiting, etc phenomenon's) B. Lab examination data C. Status of patient whether patients hospitalized or not and patient death occurred or not. The study is expected to have a pilot study for more than three months' duration. Through this EarlySense continuous monitoring and gather the data, we will analyse to develop a prediction model and confirmed with indicators. Evidences from these analytics would help to propose ways to improve it and implement Positive predictive validity models.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- above 20 years old and under hemodialysis
Exclusion Criteria:
- patient with coronary artery disease or under treatment for coronary artery disease and patient with fever, any kind of infection, or taking antibiotics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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patients under hemodialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac arrest
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Shabbir Syed-Abdul, MD, MSc, PhD, Taipei Medical University, Taiwan
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201512031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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