Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

Not Applicable

Completed

• Conditions: Automated Measurement of Vital Signs

• Registration Number: NCT02518100
• Lead Sponsor: LifeWatch Services, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Study Start: 2015-09-22
• Primary Completion: 2016-08-16
• Status Verified: 2017-04
• Study Completion: 2017-04-10
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adult male and female hospital in-patients
• Vital signs considered 'stable' by clinical caregivers

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite Outcome Measure - Successful Vital Signs Acquisition	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.

Secondary Outcome Measures

Name	Time	Method
Adhesion	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.

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States