Trial Outcomes & Findings for Vital USA Respiratory Rate Validation In Adults (NCT NCT04292639)

Last Updated: 2020-05-28

Results Overview

The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

20 Seconds

Results posted on

2020-05-28

Participant Flow

The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 yrs of any racial / ethnic background. Each subject understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test.

The subjects were healthy showing no evidence of significant medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects needed to meet all of the inclusion criteria and none of the exclusion criteria for participation.

Participant milestones

Participant milestones
Measure	Respiratory Rate The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Vital USA Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). This report documents exclusively the results of the Respiratory Rate accuracy performance for the Vital USA Vital Detect.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vital USA Respiratory Rate Validation In Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Respiratory Rate n=20 Participants This study was a comparative, single-center, non-randomized, parallel study, conducted on 20 subjects. The acceptance criteria in this study used a comparison of the Vital USA Vital Detect to a reference Respiratory Rate EtCO2 monitor. Testing was conducted under normal office environment conditions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.3 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Fitzpatrick Scale Type I Pale White Skin Blue/Green Eyes	3 Participants n=5 Participants
Fitzpatrick Scale Type II Fair Skin Blue Eyes	12 Participants n=5 Participants
Fitzpatrick Scale Type III Darker White Skin	3 Participants n=5 Participants
Fitzpatrick Scale Type IV Brown Skin	0 Participants n=5 Participants
Fitzpatrick Scale Type V Dark Brown Skin	1 Participants n=5 Participants
Fitzpatrick Scale Type VI Black Skin	1 Participants n=5 Participants
Weight	151.9 Lbs STANDARD_DEVIATION 25.9 • n=5 Participants
Height	67.3 In STANDARD_DEVIATION 3.9 • n=5 Participants
BMI	23.5 lbs/sq.In. STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: 20 Seconds

Population: The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 years and of any racial / ethnic background.

Outcome measures

Outcome measures
Measure	Respiratory Rate n=20 Participants The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).
Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.	1.39 Breaths/Min Standard Deviation 1.39

Adverse Events

Respiratory Rate

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

Mark H Khachaturian, PhD

Vital USA Inc.

Phone: +1(561)282-6074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place