A Comparative Study of the Performance of a New Type Non-contact Patient Monitor

July 30, 2012 updated by: Holux Technology, Inc.

Clinical Test of Ultra-Wideband Non-contact Heart Rate and Breath Rate Monitor

To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate and heart rate monitor, ICU bedside monitor is used as the gold standard.

Study Overview

Status

Unknown

Conditions

Detailed Description

In this study, 50 volunteer patients are tested on the UWB non-contact breath rate and heart rate monitor. The testing time length for each patient is set to two hours. Subject is not to be restrained and nurse is allowed to take care the subject while testing. The breath rate and heart rate data will be analyzed for their accuracy against the MP60 (Philips) bedside monitor.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
        • Sub-Investigator:
          • Teh-Ho Tao, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult, >18 years old.

Description

Inclusion Criteria:

  • conscious adult,
  • > 18 years old

Exclusion Criteria:

  • non-conscious,
  • pregnant women,
  • epilepsy patients,
  • patients with heart pacemaker or ACIDS,
  • patients on respirator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holux Technology, Inc.

Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Che-Ming Chang, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Holux_SKH01

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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