Clinical trial NCT02524470: Vital Signs Patch Early Feasibility and Usability Study v1.0
Official title: Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting v1.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Signs
Lead sponsor: LifeWatch Services, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.

Detailed description: The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.

The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.

This clinical study involves a device with no additional drugs administered.

During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.

Eligibility criteria: Inclusion Criteria:

* Adult male and female in-patients with 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 in the Critical Care Unit (CCU)
* Patients who otherwise satisfy any of the contraindications associated with the VSP system.

Primary outcomes:
measure: Composite Outcome Measure - 100% Successful Vital Signs Acquisition
timeFrame: Up to seven days
Secondary outcomes:
measure: Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.
timeFrame: Up to seven days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Raul Mitrani, MD FACC FHRS
role: PRINCIPAL_INVESTIGATOR
References: