Vital Signs Patch Early Feasibility and Usability Study
VSP
Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
1 other identifier
interventional
72
1 country
1
Brief Summary
To assess the feasibility and usability of the 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2014
CompletedFirst Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 4, 2017
March 1, 2017
2.2 years
August 10, 2015
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Outcome Measure - 100% Successful Vital Signs Acquisition
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, and SpO2 daily for the inpatient stay of the subject up to seven days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
Up to seven days
Secondary Outcomes (1)
Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.
Up to seven days
Study Arms (1)
VSP Study Participants
EXPERIMENTALVital Signs Patch system study participants. Each study participant will receive the VSP System - NEHB Configuration and then the VSP System - PAL Configuration. Vital signs will be taken and adhesive will be assessed for each participant for each configuration.
Interventions
VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
Eligibility Criteria
You may qualify if:
- Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mt. Sinai Medical Center
New York, New York, 10029, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Reddy, M.D.
Mt. Sinai Medical Center
- PRINCIPAL INVESTIGATOR
Marie Noelle-Langan, M.D.
Mt. Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 13, 2015
Study Start
April 16, 2014
Primary Completion
June 9, 2016
Study Completion
April 1, 2017
Last Updated
April 4, 2017
Record last verified: 2017-03