A Comparative Study of the Performance of a New Type Non-contact Patient Monitor
This study is currently recruiting participants.
Verified July 2012 by Holux Technology, Inc.
Sponsor:
Holux Technology, Inc.
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
| Tracking Information | |||||
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| First Received Date ICMJE | May 4, 2012 | ||||
| Last Updated Date | July 30, 2012 | ||||
| Start Date ICMJE | December 2011 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01592877 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparative Study of the Performance of a New Type Non-contact Patient Monitor | ||||
| Official Title ICMJE | Clinical Test of Ultra-Wideband Non-contact Heart Rate and Breath Rate Monitor | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult, >18 years old. |
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| Condition ICMJE | Indication for Modification of Patient's Cardiopulmonary Status | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | October 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01592877 | ||||
| Other Study ID Numbers ICMJE | Holux_SKH01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Holux Technology, Inc. | ||||
| Study Sponsor ICMJE | Holux Technology, Inc. | ||||
| Collaborators ICMJE | Shin Kong Wu Ho-Su Memorial Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Holux Technology, Inc. | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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