Automated Measurement of Vital SignsVSPNCT02518100
Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
A study testing Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration and Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration in people with Automated Measurement of Vital Signs, run by LifeWatch Services, Inc. at 1 site in United States.
Trial summary
This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Automated Measurement of Vital Signs
- What is being tested?
- Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration and Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2015to 10 Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- Adult male and female hospital in-patients
- Vital signs considered 'stable' by clinical caregivers
Who cannot join
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest
- Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
- Patients who are in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.
Read the detailed description
To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.
The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:
- Arterial blood oxygen Saturation (SpO2)
- ECG (up to 3 - Lead)
- Heart Rate (Part of ECG)
- Surface Temperature
- Respiration
- Conditions
- Automated Measurement of Vital Signs
- Being tested
- Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration, Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Signs Patch (VSP) System 3-Lead (NEHB) ConfigurationDevice
Vital signs will be taken using the Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility.
Vital Signs Patch (VSP) System 1-Lead (PAL) ConfigurationDevice
Vital signs will be taken using the Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility.
| Study group | Role | What they receive |
|---|---|---|
| VSP 3-Lead Study Participants | Experimental | Intervention: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 3-lead (NEHB) configuration:
Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration Receives: Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration |
| VSP 1-Lead Study Participants | Experimental | Intervention: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration. The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 1-lead (PAL) configuration:
Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration Receives: Device: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Measure - Successful Vital Signs Acquisition
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, SpO2 daily for the inpatient stay of the subject up to four days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
Measured: Up to Four Days
Secondary outcomes (1)
Adhesion
Successful performance of the adhesive of the vital signs patch during use on subjects. Adhesion will be measured as either positive or negative for each subject.
Measured: Up to Four Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start22 Sep 2015
- Primary completion16 Aug 2016
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automated Measurement of Vital SignsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeWatch Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Cantillon, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518100
- Sponsor's protocol ID
- VSP-F004
- Acronym
- VSP
- Status last verified
- Apr 2017
- First submitted
- 3 Aug 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
- ClinicalTrials.gov ID
- NCT02518100
- Acronym / sponsor ID
- VSP / VSP-F004
- Conditions
- Automated Measurement of Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LifeWatch Services, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 16 Aug 2016 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 7 Aug 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.
This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.
Detailed description
To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.
The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:
- Arterial blood oxygen Saturation (SpO2)
- ECG (up to 3 - Lead)
- Heart Rate (Part of ECG)
- Surface Temperature
- Respiration
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSP 3-Lead Study Participants | Experimental | Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) ConfigurationIntervention: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 3-lead (NEHB) configuration: Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration |
| VSP 1-Lead Study Participants | Experimental | Device: Vital Signs Patch (VSP) System 1-Lead (PAL) ConfigurationIntervention: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration. The participants of this arm will have the following vital signs taken and recorded by the VSP System in the 1-lead (PAL) configuration: Arterial blood oxygen Saturation (SpO2) ECG Heart Rate Surface Temperature Respiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and female hospital in-patients
- Vital signs considered 'stable' by clinical caregivers
Key exclusion criteria (7 listed)
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest
- Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
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 |
|---|---|---|
| Vital Signs Patch (VSP) System 3-Lead (NEHB) ConfigurationVital signs will be taken using the Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility. | Device | VSP 3-Lead Study Participants |
| Vital Signs Patch (VSP) System 1-Lead (PAL) ConfigurationVital signs will be taken using the Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility. | Device | VSP 1-Lead Study Participants |
Primary outcome
Composite Outcome Measure - Successful Vital Signs Acquisition
Time frame: Up to Four Days
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, SpO2 daily for the inpatient stay of the subject up to four days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
1 secondary outcome
Adhesion
Time frame: Up to Four Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No
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.
Daniel J Cantillon, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration and Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration in people with Automated Measurement of Vital Signs, run by LifeWatch Services, Inc. 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 12 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite Outcome Measure - Successful Vital Signs Acquisition (time frame: Up to Four Days). 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 12 Apr 2017.