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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Makani Science Respiratory Monitoring System | Device | Non-invasive Respiratory Monitoring System |
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| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | 2 hours |
| Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Analysis Results of Respiration Rate Accuracy by BMI for 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. |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Number | 95% Confidence Interval | Root Mean Squared Percentage Error | 2 hours |
|
From placement of study device to removal of study device, up to 2 hours.
Adverse events are defined as: any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether related to the study medical device.
Adverse event is assessed between placement of study device and removal of study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Arm | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Chu | Makani Science | 408 992 1882 | michael@makaniscience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2022 | Dec 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2022 | Dec 23, 2025 | SAP_001.pdf |
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| 2 hours |
| Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | 2 hours |
| Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | 2 hours |
| Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | 2 hours |
| 2 hours |
| Subgroup Analysis Results of Respiration Rate Accuracy by BMI for 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. | 2 hours |
| Subgroup Analysis Results of Respiration Rate Bias by BMI for 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. | 2 hours |
| Subgroup Analysis Results of Respiration Rate Bias by BMI for 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. | 2 hours |
| Subgroup Analysis Results of Respiration Rate Precision by BMI for 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. | 2 hours |
| Subgroup Analysis Results of Respiration Rate Precision by BMI for 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. | 2 hours |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender Distribution | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Participant Height Collected | Mean | Standard Deviation | Inches |
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| Weight | Subject Weight | Mean | Standard Deviation | lb |
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| Body Mass Index | Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Abdomen Circumference | Circumference of abdominal region | Mean | Standard Deviation | inches |
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| Torso Circumference | Circumference around chestwall | Mean | Standard Deviation | inches |
|
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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| Primary | Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Number | 95% Confidence Interval | Root Mean Squared Percentage Error | 2 hours |
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| Secondary | Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Geometric Mean | 95% Confidence Interval | percent difference | 2 hours |
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| Secondary | Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Geometric Mean | 95% Confidence Interval | percent difference | 2 hours |
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| Secondary | Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Number | 95% Confidence Interval | standard deviation of % difference | 2 hours |
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| Secondary | Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Number | 95% Confidence Interval | standard deviation of % difference | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Accuracy by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Number | 95% Confidence Interval | Root Mean Squared Percentage Error | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Accuracy by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Number | 95% Confidence Interval | Root Mean Squared Percentage Error | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Bias by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Geometric Mean | 95% Confidence Interval | percent difference | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Bias by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Geometric Mean | 95% Confidence Interval | percent difference | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Precision by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the supine position. | Posted | Number | 95% Confidence Interval | standard deviation of % difference | 2 hours |
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| Other Pre-specified | Subgroup Analysis Results of Respiration Rate Precision by BMI for 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. | Analysis is done for subjects with respiratory rate measurement taken in the recline position. | Posted | Number | 95% Confidence Interval | standard deviation of % difference | 2 hours |
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