Patient PositioningNCT02548624
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
An observational study of Patient Positioning and Monitoring, Physiologic, run by Medtronic - MITG at 1 site in United States.
Trial summary
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- What is being tested?
- Zephyr BioPatch
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 2017
- 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: The laboratory observation will consist of one non-patient subject (N=1). The hospital observation will consist of 18 patients (N=18) hospitalized at the Columbia University Medical Center on the general care floor at-risk for hospital-acquired pressure ulcers. The hospitalized subjects will be stratified into three groups. Six subjects with normal BMI classification (18.5 -24.9), six with overweight BMI classification (25.0-29.9), and six with overweight BMI classification (30.0-39.9) will comprise the study sample.
Who may be able to join
- Signed and dated informed consent by subject
- Male or female of any race
- At least 18 years of age
- Willingness to have study device attached during study participation
- Willingness to participate in all aspects of the study
- Signed and dated informed consent by subject
Show all 12Show fewer
- Male or female of any race
- At least 18 years of age
- Expected hospitalized admission on the general care floor for at least three days
- At risk for hospital-acquired pressure ulcers as defined by score on the Braden Scale of < 18
- Willingness to have study devices attached during study participation
- Willingness to participate in all aspects of the study
Who cannot join
- Implanted pacemaker or defibrillator
- Allergy or sensitivity to ECG leads or similar types of adhesive
- History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
- BMI > 30.0
- Implanted pacemaker or defibrillator
- Allergy or sensitivity to ECG leads or similar types of adhesive
- Subject will be sleeping in a chair or spending the majority of time in a chair
- BMI > 39.9
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.
- Conditions
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- Being tested
- Zephyr BioPatch
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zephyr BioPatchDevice
Also called ZephyrLIFE Hospital System
The ZephyrLIFE Hospital System includes the BioPatch™ device (consisting of the BioModule™ sensor, BioModule™ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModule™ sensor is a Class II device, 510(k) cleared by the FDA, and commercially available.
The ZephyrLIFE Hospital System stores, transmits and displays vital sign data including ECG, HR, RR, body orientation, and activity to caregivers via a central station.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body position
Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Measured: During a 2.5 hour lab observation
Body position
Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Measured: During a 24 hospital observation
Secondary outcomes (1)
Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)
Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Measured: During a 24 hospital observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startNov 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Protocol is being reevaluated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PositioningStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Adelman, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548624
- Sponsor's protocol ID
- COVMOPO0520
- Status last verified
- Apr 2017
- First submitted
- 1 Sep 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
- ClinicalTrials.gov ID
- NCT02548624
- Acronym / sponsor ID
- COVMOPO0520
- Conditions
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol is being reevaluated by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 14 Sep 2015 (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.
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.
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
- The laboratory observation will consist of one non-patient subject (N=1). The hospital observation will consist of 18 patients (N=18) hospitalized at the Columbia University Medical Center on the general care floor at-risk for hospital-acquired pressure ulcers. The hospitalized subjects will be stratified into three groups. Six subjects with normal BMI classification (18.5 -24.9), six with overweight BMI classification (25.0-29.9), and six with overweight BMI classification (30.0-39.9) will comprise the study sample.
Key inclusion criteria (12 listed)
- Signed and dated informed consent by subject
- Male or female of any race
- At least 18 years of age
- Willingness to have study device attached during study participation
- Willingness to participate in all aspects of the study
Key exclusion criteria (8 listed)
- Implanted pacemaker or defibrillator
- Allergy or sensitivity to ECG leads or similar types of adhesive
- History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
- BMI > 30.0
- Implanted pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zephyr BioPatchAlso: ZephyrLIFE Hospital SystemThe ZephyrLIFE Hospital System includes the BioPatch™ device (consisting of the BioModule™ sensor, BioModule™ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModule™ sensor is a Class II device, 510(k) cleared by the FDA, and commercially available. The ZephyrLIFE Hospital System stores, transmits and displays vital sign data including ECG, HR, RR, body orientation, and activity to caregivers via a central station. | Device | – |
Primary outcome
Body position
Time frame: During a 2.5 hour lab observation
Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Body position
Time frame: During a 24 hospital observation
Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
1 secondary outcome
Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)
Time frame: During a 24 hospital observation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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.
Jason Adelman, MD, MS principal investigator
Columbia University
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 Patient Positioning and Monitoring, Physiologic, run by Medtronic - MITG at 1 site in United States.
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 12 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Apr 2017. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body position (time frame: During a 2.5 hour lab observation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.