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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 (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Arm | Experimental | Subjects with both the reference and experimental device placed for paired data collection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Makani Science Respiratory Monitoring System | Device | Subjects monitored by the Makani Science Respiratory Monitoring System |
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| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Accuracy Compared Between Experimental and Reference Devices | Mean absolute error (MAE) was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). MAE was defined as the average of the absolute differences between the experimental and reference measurements. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE. Device performance was considered acceptable if the MAE was within 3 breaths per minute (BPM) of the reference device. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Bias Compared Between Experimental and Reference Devices | Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). Bias was defined as the average of the differences between the experimental and reference measurements. A negative bias indicates the experimental device underreports the measurement. The lower and upper bounds of the 95% confidence interval were also calculated for each biase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illumination Foundation | Fullerton | California | 92833 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Arm | Subjects with both the reference and experimental device placed for paired data collection Makani Science Respiratory Monitoring System: Subjects monitored by the Makani Science Respiratory Monitoring System |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Arm | Subjects with both the reference (Gold Standard method - capnography) and experimental device (Makani Science Non-INvasive Respiratory Monitoring System) used to collect respiratory rate data simultaneously (paired data collection) under different conditions (breathing normally, breathing artifacts, and changing positions). |
| 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 | Average age of subject population was calculated in terms of mean and standard deviation. Age was reported but not used in any sub-group analysis. |
| 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 Compared Between Experimental and Reference Devices | Mean absolute error (MAE) was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). MAE was defined as the average of the absolute differences between the experimental and reference measurements. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE. Device performance was considered acceptable if the MAE was within 3 breaths per minute (BPM) of the reference device. | Patient in Supine Position Breathing Normally. | Posted | Mean | 95% Confidence Interval | Breath Per Minute | 1 hour |
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From experimental device placement to when experimental device was removed, an average of 2 hours
All subjects had their respiratory rate measured by the gold standard method (capnography) and Non-Invasive Respiratory Monitoring System (RMS) simultaneously while performing quite breathing, simulated artifacts, and position change. The time frame for the adverse event monitoring starts with the placement of both devices and ends with the removal of both devices. Since both devices will be operating simulatneously during the monitoring, they are reported as a single arm/group.
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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 | Subjects with both the reference (Gold Standard method - capnography) and experimental device (Makani Science Non-INvasive Respiratory Monitoring System) used to collect respiratory rate data simultaneously (paired data collection) under different conditions (breathing normally, breathing artifacts, and changing positions). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged pauses in breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject fell asleep during the quiet breathing protocol. Loud snoring was heard with long pauses in breathing. Subject was woken up. The event was determined not related to the study since the devices did not obstruct the mouth or nose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Chu | Makani Science | (949) 427-5208 | 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 | May 8, 2024 | Dec 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2024 | Dec 23, 2025 | SAP_001.pdf |
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| 1 hour |
| Makani Science System Performance After Simulated Breathing Artifacts | Mean absolute error (MAE) and Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after subject performed simulated breathing artifacts. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and Bias. | 15 minutes |
| Makani Science System Performance With Subject Laying on the Right Side | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their right side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | 15 minutes |
| Makani Science System Performance With Subject Laying on the Left Side | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their left side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | 15 minutes |
| Makani Science System Performance With Subject Laying in the Reclined Position | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to the reclined position. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | 15 minutes |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Gender distribution of the subject population was reported in terms of male or female. A sub-group analysis was performed comparing accuracy between male and female. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Skin Color | Fitzpatrick scale was used to quantify patient skin type from type I (pale) to type VI (dark). Skin color was reported but not used in any sub-group analysis. | Number | Fitzpatrick Scale |
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| Body Mass Index | Body mass index was calculated based on patient's height and weight. A sub-group analysis was performed comparing accuracy between normal (BMI < 25 kg/m^2) and overweight (BMI >=25 kg/m^2) subjects. | Count of Participants | Participants |
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| Height | Average height of subject population was calculated in terms of mean and standard deviation. Height was used to calculate BMI, but not directly used in any sub-group analysis. | Mean | Standard Deviation | centimeters |
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| Weight | Average weight of subject population was calculated in terms of mean and standard deviation. weight was used to calculate BMI, but not directly used in any sub-group analysis. | Mean | Standard Deviation | kilogram |
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| Secondary | Respiratory Rate Bias Compared Between Experimental and Reference Devices | Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). Bias was defined as the average of the differences between the experimental and reference measurements. A negative bias indicates the experimental device underreports the measurement. The lower and upper bounds of the 95% confidence interval were also calculated for each biase. | Respiratory rate bias in supine patients breathing normally | Posted | Number | 95% Confidence Interval | Breath Per Minute | 1 hour |
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| Secondary | Makani Science System Performance After Simulated Breathing Artifacts | Mean absolute error (MAE) and Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after subject performed simulated breathing artifacts. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and Bias. | Mean absolute error measured in supine patients after simulated breathing artifacts were performed. | Posted | Mean | 95% Confidence Interval | Breath Per Minute | 15 minutes |
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| Secondary | Makani Science System Performance With Subject Laying on the Right Side | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their right side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | Analysis was done on subjects with data collected while laying on right side. | Posted | Mean | 95% Confidence Interval | Breath Per Minute | 15 minutes |
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| Secondary | Makani Science System Performance With Subject Laying on the Left Side | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their left side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | Analysis was done on subjects with data collected while laying on their left side | Posted | Mean | 95% Confidence Interval | Breath Per Minute | 15 minutes |
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| Secondary | Makani Science System Performance With Subject Laying in the Reclined Position | Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to the reclined position. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase. | Analysis was done on subjects with data collected while laying in the reclind position. | Posted | Mean | 95% Confidence Interval | Breath Per Minute | 15 minutes |
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