Makani Science Respiratory Monitoring System
DeviceNon-invasive Respiratory Monitoring System
NCT Number: NCT06000852
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (manual counting) in healthy human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.
Participants will be asked to breath normally and according to a number of different procedure while wearing both monitors.
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Notify Me22 year–99 year
All sexes
Interventional
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive Respiratory Monitoring System
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Michael Chu
Industry
Makani Science Respiration Monitoring System Pivotal Clinical Study Protocol
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