Trial Outcomes & Findings for Comparison of Non-Invasive Respiratory Monitoring System (RMS) (NCT NCT06000852)
NCT ID: NCT06000852
Last Updated: 2026-03-25
Results Overview
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject was in the supine position. For each paired measurement, the percent difference is calculated. The root mean square percent error (RMSE) is then calculated across all paired supine measurements for all subjects. The RMSE is calculated by taking the square root of the average of the squared percent differences between each measured value from the respiratory monitroing system and its corresponding reference value from the manual counting.The 95% confidence intervals is calculated for the RMSE.
COMPLETED
27 participants
2 hours
2026-03-25
Participant Flow
Participant milestones
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Overall Study
STARTED
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27
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Overall Study
Pariticpant with quiet breathing supin position
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23
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Overall Study
Participants with quiet breathing in recline position
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25
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Overall Study
Respiratory Monitoring System device failure
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=26 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Age, Continuous
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33.6 Years
STANDARD_DEVIATION 12.3 • n=26 Participants
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Sex: Female, Male
Female
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17 Participants
n=26 Participants
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Sex: Female, Male
Male
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9 Participants
n=26 Participants
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Height
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66.2 Inches
STANDARD_DEVIATION 3.4 • n=26 Participants
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Weight
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149.8 lb
STANDARD_DEVIATION 24.9 • n=26 Participants
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Body Mass Index
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24.1 kg/m^2
STANDARD_DEVIATION 3.5 • n=26 Participants
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Abdomen Circumference
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33.1 inches
STANDARD_DEVIATION 3.9 • n=26 Participants
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Torso Circumference
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34.2 inches
STANDARD_DEVIATION 3.6 • n=26 Participants
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PRIMARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject was in the supine position. For each paired measurement, the percent difference is calculated. The root mean square percent error (RMSE) is then calculated across all paired supine measurements for all subjects. The RMSE is calculated by taking the square root of the average of the squared percent differences between each measured value from the respiratory monitroing system and its corresponding reference value from the manual counting.The 95% confidence intervals is calculated for the RMSE.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
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22.9 Root Mean Squared Percentage Error
Interval 18.7 to 26.9
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PRIMARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent difference is calculated. The root mean square percent error (RMSE) is then calculated across all paired recline measurements for all subjects. The RMSE is calculated by taking the square root of the average of the squared percent differences between each measured value from the respiratory monitroing system and its corresponding reference value from the manual counting.The 95% confidence intervals is calculated for the RMSE.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
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25 Root Mean Squared Percentage Error
Interval 21.0 to 28.5
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SECONDARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the supine position. For each paired measurement, the percent bias is calculated across all paired supine measurements for all subjects. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. The 95% confidence intervals is calculated for the bias.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
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.1 percent difference
Interval -3.9 to 3.9
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SECONDARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent bias is calculated across all paired recline measurements for all subjects. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. The 95% confidence intervals is calculated for the bias.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
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6.7 percent difference
Interval 3.4 to 9.9
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SECONDARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the supine position. For each paired measurement, the percent precision is calculated across all paired supine measurements for all subjects. Precision can be interpreted as the standard deviation of the relative paired differences. The 95% confidence intervals is calculated for the precision.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
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22.9 standard deviation of % difference
Interval 18.5 to 26.8
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SECONDARY outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent precision is calculated across all paired recline measurements for all subjects. Precision can be interpreted as the standard deviation of the relative paired differences. The 95% confidence intervals is calculated for the precision.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
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24.1 standard deviation of % difference
Interval 20.4 to 27.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The root mean square percent error (RMSPE) will be calculated separately for each BMI category, and a randomization test will be used to assess whether RMSPE differs between the two BMI groups. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Supine Position
Normal BMI
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25.9 Root Mean Squared Percentage Error
Interval 21.1 to 30.4
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Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Supine Position
Overweight BMI
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14.3 Root Mean Squared Percentage Error
Interval 10.7 to 17.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The root mean square percent error (RMSPE) will be calculated separately for each BMI category, and a randomization test will be used to assess whether RMSPE differs between the two BMI groups. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Recline Position
Normal BMI
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24.2 Root Mean Squared Percentage Error
Interval 20.3 to 27.8
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Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Recline Position
Overweight BMI
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27.6 Root Mean Squared Percentage Error
Interval 16.5 to 36.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The bias will be calculated separately for each BMI category. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Bias by BMI for Supine Position
Normal BMI
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-.5 percent difference
Interval -5.9 to 4.9
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Subgroup Analysis Results of Respiration Rate Bias by BMI for Supine Position
Overweight BMI
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1.5 percent difference
Interval -3.1 to 5.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The bias will be calculated separately for each BMI category. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Bias by BMI for Recline Position
Normal BMI
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4.9 percent difference
Interval 1.6 to 8.3
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Subgroup Analysis Results of Respiration Rate Bias by BMI for Recline Position
Overweight BMI
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11.9 percent difference
Interval 3.6 to 20.6
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The precision will be calculated separately for each BMI category. Precision can be interpreted as the standard deviation of the relative paired differences. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=23 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Precision by BMI for Supine Position
Normal BMI
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25.9 standard deviation of % difference
Interval 20.7 to 30.3
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Subgroup Analysis Results of Respiration Rate Precision by BMI for Supine Position
Overweight BMI
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14.2 standard deviation of % difference
Interval 10.5 to 16.6
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: Analysis is done for subjects with respiratory rate measurement taken in the recline position.
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI \< 25; overweight: BMI ≥ 25). The precision will be calculated separately for each BMI category. Precision can be interpreted as the standard deviation of the relative paired differences. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
Outcome measures
| Measure |
Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting)
n=25 Participants
A single cohort of subjects underwent respiratory monitoring using the non-invasive respiratory monitoring system (RMS) and a gold-standard reference (manual counting). Subjects performed 11 distinct breathing maneuvers, each conducted once in the supine position and once in the reclined position. Subjects were included in the analysis if they completed at least one of the 11 breathing maneuvers.
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Subgroup Analysis Results of Respiration Rate Precision by BMI for Recline Position
Normal BMI
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23.7 standard deviation of % difference
Interval 19.9 to 27.1
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Subgroup Analysis Results of Respiration Rate Precision by BMI for Recline Position
Overweight BMI
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25 standard deviation of % difference
Interval 16.1 to 31.4
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Adverse Events
Device Arm
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