Trial Outcomes & Findings for Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application (NCT NCT06508047)
NCT ID: NCT06508047
Last Updated: 2026-03-18
Results Overview
The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference (Ref) Respiratory Rate as counted using the End Tidal Carbon Dioxide scored waveform by counting the respiratory peaks per minute for all stable respiratory periods.
Recruitment status
COMPLETED
Target enrollment
68 participants
Primary outcome timeframe
60 seconds
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
Informed Vital Core App
All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.
Informed Vital Core App: Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.
|
|---|---|
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Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Informed Vital Core App
All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.
Informed Vital Core App: Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.
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|---|---|
|
Overall Study
Poor data quality
|
1
|
|
Overall Study
end-tidal carbon dioxide stayed low
|
1
|
|
Overall Study
premature ventricular contractions
|
1
|
Baseline Characteristics
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Baseline characteristics by cohort
| Measure |
Informed Vital Core App
n=65 Participants
All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.
Informed Vital Core App: Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=110 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=110 Participants
|
|
Age, Continuous
|
49 years
n=110 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=110 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=110 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: 60 secondsThe endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference (Ref) Respiratory Rate as counted using the End Tidal Carbon Dioxide scored waveform by counting the respiratory peaks per minute for all stable respiratory periods.
Outcome measures
| Measure |
Informed Vital Core App
n=391 breaths per minute
All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.
Informed Vital Core App: Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.
|
|---|---|
|
Respiratory Rate Accuracy
|
0.91 breaths per minute
Interval -1.76 to 1.82
|
Adverse Events
Informed Vital Core App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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