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Clinical Validation of Non-Contact Vital Signs
Sponsor: Presage Technologies, Inc.
Summary
Vital signs are critically important to modern emergency medical care. These metrics (heart rate (HR), respiratory rate (RR), blood pressure, temperature, and pulse oximetry) have been shown to predict a patient's morbidity, mortality, need for ICU-level admission, and suitability for discharge. As such, vital signs are used at multiple points of emergency department (ED) care, from triage through treatment through disposition. Unfortunately, the acquisition of vital signs can be a time-intensive process. Time-and-motion studies have shown the measurement and recording of vital signs may take over five minutes per patient and longer with interruptions.5 Increased crowding, lack of available staff, and length-of-stay have all been shown to delay or decrease the frequency of vital sign measurements. Some studies have shown a majority of both children and adults may be missing vital signs during their ED stays. Other studies have shown repeat vital signs to be taken less frequently every two hours. With increasing boarding and crowding in ED settings, the frequency of vital sign acquisition may be significantly worse than this reported data. Many emergency departments have sought to improve vital sign acquisition through various quality improvement initiatives. Some researchers have also evaluated alternative means of vital sign acquisition. Telemedical providers, for instance, have evaluated the accuracy of patients' self-reported vital signs. Device studies have also looked at non-contact vital signs via radar and thermal imaging. More recently, studies have evaluated the feasibility of acquiring vital signs using cameras. These studies of camera-acquired vital signs have shown promise, though they are limited by small sample sizes. Here, we present the clinical validation of camera-acquired vital signs obtained from commercially available products over a larger sample size.
Official title: Clinical Validation of Non-Contact Vital Signs in an Emergency Department Setting
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
111
Start Date
2025-03-28
Completion Date
2025-04-21
Last Updated
2026-08-24
Healthy Volunteers
Yes
Conditions
Interventions
SmartSpectra Vital Signs Monitor measurement
The objective of the study was to evaluate the safety and effectiveness of the SmartSpectra Vital Signs Monitor version 1.0.0 vis-a-vis standard-of-care, FDA-cleared Philips Intellivue MX450 patient monitor device (FDA Clearance K130849)("MX450"). The MX450 measures end-tidal CO2 ("EtCO2") and three-lead electrocardiogram ("ECG") waveforms.
Locations (1)
Ben Taub Hospital
Houston, Texas, United States