Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
- Conditions
- Automated Measurement of Vital Signs
- Interventions
- Device: Vital Signs Patch (VSP) System 1-Lead (PAL) ConfigurationDevice: Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Adult male and female hospital in-patients
- Vital signs considered 'stable' by clinical caregivers
- 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
- Arm && Interventions
Group Intervention Description VSP 1-Lead Study Participants Vital Signs Patch (VSP) System 1-Lead (PAL) 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 VSP 3-Lead Study Participants Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration 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
- 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