Indication for Modification of Patient's Cardiopulmonary StatusNCT01592877
A Comparative Study of the Performance of a New Type Non-contact Patient Monitor
An observational study of Indication for Modification of Patient's Cardiopulmonary Status, run by Holux Technology, Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Indication for Modification of Patient's Cardiopulmonary Status
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, >18 years old.
Who may be able to join
- conscious adult,
- > 18 years old
Who cannot join
- non-conscious,
- pregnant women,
- epilepsy patients,
- patients with heart pacemaker or ACIDS,
- patients on respirator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Shu-Ping Chao, MD, 886-968-995076, m006448@ms.skh.org.tw
Teh-Ho Tao, Ph.D.
About this study
Official title: 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.
Read the 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.
- Keywords
- UWB, non-contact, patient monitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Modification of Patient's Cardiopulmonary StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holux Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Che-Ming Chang, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592877
- Sponsor's protocol ID
- Holux_SKH01
- Status last verified
- Jul 2012
- First submitted
- 4 May 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Test of Ultra-Wideband Non-contact Heart Rate and Breath Rate Monitor
- ClinicalTrials.gov ID
- NCT01592877
- Acronym / sponsor ID
- Holux_SKH01
- Keywords
- UWB, non-contact, patient monitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Holux Technology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, >18 years old.
Key inclusion criteria (2 listed)
- conscious adult,
- > 18 years old
Key exclusion criteria (5 listed)
- non-conscious,
- pregnant women,
- epilepsy patients,
- patients with heart pacemaker or ACIDS,
- patients on respirator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Che-Ming Chang, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Modification of Patient's Cardiopulmonary Status, run by Holux Technology, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.