An interventional study of Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration and Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration in Automated Measurement of Vital Signs, sponsored by LifeWatch Services, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by LifeWatch Services, Inc. · Not applicable, Interventional, and Supportive care
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.
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:
LifeWatch Services, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration
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
Device: Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration
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 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.
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.
Time frame: Up to Four Days
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.
Time frame: Up to Four Days
Plan to share: No
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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LifeWatch Services, Inc.