Trial Outcomes & Findings for MightySat - Clinical Performance Comparison Study (NCT NCT03239574)
NCT ID: NCT03239574
Last Updated: 2020-12-31
Results Overview
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
COMPLETED
34 participants
approximately 30-40 minutes
2020-12-31
Participant Flow
Participant milestones
| Measure |
MightySat Test Group
The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MightySat - Clinical Performance Comparison Study
Baseline characteristics by cohort
| Measure |
MightySat Test Group
n=34 Participants
The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: approximately 30-40 minutesAccuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Outcome measures
| Measure |
MightySat Test Group
n=34 Participants
The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
|
|---|---|
|
Accuracy of RRp Determination
|
1.9 breaths per minute
|
Adverse Events
MightySat Test Group
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