Trial Outcomes & Findings for Clinical Validation of Non-Contact Vital Signs (NCT NCT07362641)
NCT ID: NCT07362641
Last Updated: 2026-08-24
Results Overview
One co-primary endpoint was evaluation of the accuracy and robustness of pulse rate measurements from the SmartSpectra Vital Sign Monitor app versus a standard-of-care, FDA cleared Philips Intellivue MX450 patient monitor. That is, the Outcome Measure is the difference between the SmartSpectra Vital Sign Monitor App and the standard-of-care Philips patient monitor. The pulse rate from the Philips patient monitor is the 'actual' pulse rate and the pulse rate from the SmartSpectra App is the 'measured' pulse rate and the Outcome Measure is, therefore, the difference between the actual and measured pulse rate. Pulse rate is reported as beats per minute.
COMPLETED
111 participants
From enrollment to completion of pulse rate measurement was between 15 and 30 minutes.
2026-08-24
Participant Flow
One hundred and eleven subjects participated in the study. These included hospital employees and friends and family members of patients in the Emergency Department.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Relatively Healthy Patients, Visitors, or Employees Located in a Hospital ER
n=111 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=111 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
108 Participants
n=111 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=111 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=111 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=111 Participants
|
PRIMARY outcome
Timeframe: From enrollment to completion of pulse rate measurement was between 15 and 30 minutes.Population: One-hundred and eleven subjects were enrolled at an urban academic teaching hospital in Texas. Heart rate (HR) and respiratory rate (RR) measurements were obtained using three commercially-available cameras and processed using software from Presage Technologies. These values were compared to manual counts of a three-lead ECG and end-tidal CO2 from a patient monitor.
One co-primary endpoint was evaluation of the accuracy and robustness of pulse rate measurements from the SmartSpectra Vital Sign Monitor app versus a standard-of-care, FDA cleared Philips Intellivue MX450 patient monitor. That is, the Outcome Measure is the difference between the SmartSpectra Vital Sign Monitor App and the standard-of-care Philips patient monitor. The pulse rate from the Philips patient monitor is the 'actual' pulse rate and the pulse rate from the SmartSpectra App is the 'measured' pulse rate and the Outcome Measure is, therefore, the difference between the actual and measured pulse rate. Pulse rate is reported as beats per minute.
Outcome measures
| Measure |
Relatively Healthy Patients, Visitors, or Employees Located in a Hospital ER
n=111 Participants
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.
|
|---|---|
|
Difference in Pulse Rate Measurements (Beats Per Minute) Between SmartSpectra Vital Sign Monitor App and the Standard-of-Care Philips Patient Monitor
|
1.62 Beats per minute
Interval 1.1 to 2.14
|
PRIMARY outcome
Timeframe: From enrollment to completion of breathing rate measurement was between 15 and 30 minutes.Population: One-hundred and eleven subjects were enrolled at an urban academic teaching hospital in Texas. Heart rate (HR) and respiratory rate (RR) measurements were obtained using three commercially-available cameras and processed using software from Presage Technologies. These values were compared to manual counts of a three-lead ECG and end-tidal CO2 from a patient monitor.
One co-primary endpoint was evaluation of the accuracy and robustness of breathing rate measurements from the SmartSpectra Vital Sign Monitor app versus a standard-of-care, FDA cleared Philips Intellivue MX450 patient monitor. That is, the Outcome Measure is the difference between the SmartSpectra Vital Sign Monitor App and the standard-of-care Philips patient monitor. The breathing rate from the Philips patient monitor is the 'actual' breathing rate and the breathing rate from the SmartSpectra App is the 'measured' breathing rate and the Outcome Measure is, therefore, the difference between the actual and measured breathing rate. This measurement may also be referred to as respiration rate. Breathing rate is reported in units of breaths per minute.
Outcome measures
| Measure |
Relatively Healthy Patients, Visitors, or Employees Located in a Hospital ER
n=111 Participants
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.
|
|---|---|
|
Difference in Breathing Rate Measurements (Breaths Per Minute) Between SmartSpectra Vital Sign Monitor App and the Standard-of-Care Philips Patient Monitor
|
1.71 Breaths per minute
Interval 1.53 to 1.89
|
Adverse Events
Relatively Healthy Patients, Visitors, or Employees Located in a Hospital ER
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place