Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
NCT ID: NCT02518100
Last Updated: 2017-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2015-09-22
2017-04-10
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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VSP 3-Lead Study Participants
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
Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration
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.
VSP 1-Lead Study Participants
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
Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration
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.
Interventions
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Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration
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 Patch (VSP) System 1-Lead (PAL) Configuration
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.
Eligibility Criteria
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Inclusion Criteria
* Vital signs considered 'stable' by clinical caregivers
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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LifeWatch Services, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel J Cantillon, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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The Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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VSP-F004
Identifier Type: -
Identifier Source: org_study_id
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