Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Automated Measurement of Vital Signs
- Sponsor
- LifeWatch Services, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Composite Outcome Measure - Successful Vital Signs Acquisition
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adhesion(Up to Four Days)