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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Holux Technology, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Shin Kong Wu Ho-Su Memorial Hospital
Information provided by (Responsible Party):
Holux Technology, Inc.
ClinicalTrials.gov Identifier:
NCT01592877
First received: May 4, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition
Indication for Modification of Patient's Cardiopulmonary Status

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Test of Ultra-Wideband Non-contact Heart Rate and Breath Rate Monitor

Further study details as provided by Holux Technology, Inc.:

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult, >18 years old.

Criteria

Inclusion Criteria:

  • conscious adult,
  • > 18 years old

Exclusion Criteria:

  • non-conscious,
  • pregnant women,
  • epilepsy patients,
  • patients with heart pacemaker or ACIDS,
  • patients on respirator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592877

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Shu-Ping Chao, MD    886-968-995076    m006448@ms.skh.org.tw   
Sub-Investigator: Teh-Ho Tao, Ph.D.         
Sponsors and Collaborators
Holux Technology, Inc.
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Principal Investigator: Che-Ming Chang, MD Shin Kong Wu Ho-Su Memorial Hospital
  More Information

No publications provided

Responsible Party: Holux Technology, Inc.
ClinicalTrials.gov Identifier: NCT01592877     History of Changes
Other Study ID Numbers: Holux_SKH01
Study First Received: May 4, 2012
Last Updated: July 30, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Holux Technology, Inc.:
UWB
non-contact
patient monitor

ClinicalTrials.gov processed this record on July 24, 2014