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Clinical Validation of Non-Contact Vital Signs

NCT07362641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Vital Sign Evaluation

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Presage Technologies, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2025-04-21
Completion
2025-04-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362641 on ClinicalTrials.gov