The Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT02518100
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to Four Days
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.
LifeWatch Services, Inc.
Industry
Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
Acronym: VSP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.