Trial Outcomes & Findings for Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR) (NCT NCT06521385)
NCT ID: NCT06521385
Last Updated: 2026-03-16
Results Overview
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.
COMPLETED
NA
32 participants
1 hour
2026-03-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
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Overall Study
STARTED
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32
|
|
Overall Study
Breathing Normally
|
26
|
|
Overall Study
Simulated Breathing Artifact
|
24
|
|
Overall Study
Position Change (Right Side)
|
3
|
|
Overall Study
Position Change (Left Side)
|
13
|
|
Overall Study
Position Change (Reclined)
|
8
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Device Arm
n=29 Participants
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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|---|---|
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Age, Continuous
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49.6 Years
STANDARD_DEVIATION 16.3 • n=29 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=29 Participants
|
|
Skin Color
I
|
3 Fitzpatrick Scale
n=29 Participants
|
|
Skin Color
II
|
5 Fitzpatrick Scale
n=29 Participants
|
|
Skin Color
III
|
7 Fitzpatrick Scale
n=29 Participants
|
|
Skin Color
IV
|
8 Fitzpatrick Scale
n=29 Participants
|
|
Skin Color
V
|
5 Fitzpatrick Scale
n=29 Participants
|
|
Skin Color
VI
|
1 Fitzpatrick Scale
n=29 Participants
|
|
Body Mass Index
Normal (BMI < 25)
|
12 Participants
n=29 Participants
|
|
Body Mass Index
Overweight (BMI >=25)
|
17 Participants
n=29 Participants
|
|
Height
|
166.4 centimeters
STANDARD_DEVIATION 12.3 • n=29 Participants
|
|
Weight
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72 kilogram
STANDARD_DEVIATION 13.1 • n=29 Participants
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PRIMARY outcome
Timeframe: 1 hourPopulation: Patient in Supine Position Breathing Normally.
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.
Outcome measures
| Measure |
Device Arm
n=26 Participants
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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|---|---|
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Respiratory Rate Accuracy Compared Between Experimental and Reference Devices
|
.63 Breath Per Minute
Interval 0.49 to 0.8
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SECONDARY outcome
Timeframe: 1 hourPopulation: Respiratory rate bias in supine patients breathing normally
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.
Outcome measures
| Measure |
Device Arm
n=26 Participants
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).
|
|---|---|
|
Respiratory Rate Bias Compared Between Experimental and Reference Devices
|
-.40 Breath Per Minute
Interval -0.56 to -0.27
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SECONDARY outcome
Timeframe: 15 minutesPopulation: Mean absolute error measured in supine patients after simulated breathing artifacts were performed.
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.
Outcome measures
| Measure |
Device Arm
n=24 Participants
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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|---|---|
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Makani Science System Performance After Simulated Breathing Artifacts
Mean Average Error
|
.57 Breath Per Minute
Interval 0.4 to 0.75
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|
Makani Science System Performance After Simulated Breathing Artifacts
Bias
|
-.38 Breath Per Minute
Interval -0.58 to -0.19
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SECONDARY outcome
Timeframe: 15 minutesPopulation: Analysis was done on subjects with data collected while laying on 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.
Outcome measures
| Measure |
Device Arm
n=3 Participants
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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Makani Science System Performance With Subject Laying on the Right Side
Mean Average Error
|
.67 Breath Per Minute
Interval 0.0 to 1.5
|
|
Makani Science System Performance With Subject Laying on the Right Side
Bias
|
-.67 Breath Per Minute
Interval -1.5 to 0.0
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SECONDARY outcome
Timeframe: 15 minutesPopulation: Analysis was done on subjects with data collected while laying on their 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.
Outcome measures
| Measure |
Device Arm
n=13 Participants
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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Makani Science System Performance With Subject Laying on the Left Side
Mean Average Error
|
1.49 Breath Per Minute
Interval 0.38 to 3.04
|
|
Makani Science System Performance With Subject Laying on the Left Side
Bias
|
-1.49 Breath Per Minute
Interval -3.04 to -0.38
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SECONDARY outcome
Timeframe: 15 minutesPopulation: Analysis was done on subjects with data collected while laying in the reclind 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.
Outcome measures
| Measure |
Device Arm
n=8 Participants
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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|---|---|
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Makani Science System Performance With Subject Laying in the Reclined Position
Mean Average Error
|
1.38 Breath Per Minute
Interval 0.31 to 3.06
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|
Makani Science System Performance With Subject Laying in the Reclined Position
Bias
|
-1.25 Breath Per Minute
Interval -2.94 to -0.19
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Adverse Events
Device Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Device Arm
n=29 participants at risk
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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Respiratory, thoracic and mediastinal disorders
Prolonged pauses in breathing
|
3.4%
1/29 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place