Clinical Validation of Non-Contact Vital Signs

NCT07362641 | Completed FDA Device

• 2 other identifiers: H-54364HQ08452390071
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rPPG; remote photoplethysmography; PPG from video signal; No contact measurement respiration rate and pulse rate; Vital signs measurement; Respiration rate; Pulse rate; heart rate

Outcome Measures

Primary Outcomes (2)

• Pulse Rate Measurement, Beats per minute

  One co-primary endpoint was evaluation of the accuracy and robustness of pulse rate measurements from iPhone and Android deployments of the SmartSpectra Vital Sign Monitor app versus a standard-of-care, FDA cleared Philips Intellivue MX450 patient monitor. Pulse rate is reported as beats per minute.

  From enrollment to completion of pulse rate measurement was between 15 and 30 minutes.

• Breathing (Respiration) Rate Measurement, Breaths per Minute

  One co-primary endpoint was evaluation of the accuracy and robustness of breathing rate measurements from iPhone and Android deployments of the SmartSpectra Vital Sign Monitor app versus a standard-of-care, FDA cleared Philips Intellivue MX450 patient monitor. This measurement may also be referred to as respiration rate. Breathing rate is reported in units of breaths per minute.

  From enrollment to completion of breathing rate measurement was between 15 and 30 minutes.

Study Arms (1)

Relatively healthy patients, visitors, or employees located in a hospital ER

Potential subjects were screened based on exclusion/inclusion criteria. Subject decision making capacity was determined by the research staff approaching the subject. No one was approached for participation while undergoing medical treatment, and a subject must be oriented to person, place, time to participate. Other than decision making capacity, inclusion criteria was patients, visitors or employees greater than 18 years of age and less than 75 years old. Exclusion criteria, other than lack of decision making capacity, were patients requiring immediate medical care, persons with facial scarring, age less than 18 years old, age greater than 75 years old, employees of Presage Technologies, self-reported pregnancy and anyone who does not pass the screening questionnaire.

Device: SmartSpectra Vital Signs Monitor measurement

Interventions

SmartSpectra Vital Signs Monitor measurement DEVICE

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.

Relatively healthy patients, visitors, or employees located in a hospital ER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Located in Ben Taub Emergency Department of Harris County Hospital District

You may qualify if:

• Subject decision making capacity;
• Subject not undergoing medical treatment;
• Subject oriented to person, place, time;
• Subject is a patient, visitor or employee to Ben Taub Hospital;
• Subject greater than 18 years of age and less than 75 years old.

You may not qualify if:

• Subject is employee of Presage Technologies;
• Subject pregnant;
• Subject does not pass screening questionnaire.

Sponsors & Collaborators

• Presage Technologies, Inc.: lead

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 23, 2026
• Study Start: March 28, 2025
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)