Respiratory Monitoring
Conditions
Brief summary
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.
Interventions
Subjects monitored by the Makani Science Respiratory Monitoring System
Sponsors
Makani Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Between age of 22-99 * BMI between 15 and 40 kg/m\^2
Exclusion criteria
* Medical history of serious symptomatic, cardiac, or pulmonary disease. * History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape). * Cannot lay still for one (1) hour. * Cannot give written informed consent. * Unable to follow instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Accuracy Compared Between Experimental and Reference Devices | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Bias Compared Between Experimental and Reference Devices | 1 hour | 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. |
| Makani Science System Performance After Simulated Breathing Artifacts | 15 minutes | 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. |
| Makani Science System Performance With Subject Laying on the Right Side | 15 minutes | 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. |
| Makani Science System Performance With Subject Laying on the Left Side | 15 minutes | 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. |
| Makani Science System Performance With Subject Laying in the Reclined Position | 15 minutes | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.6 Years STANDARD_DEVIATION 16.3 |
| Body Mass Index Normal (BMI < 25) | 12 Participants |
| Body Mass Index Overweight (BMI >=25) | 17 Participants |
| Height | 166.4 centimeters STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 15 Participants |
| Skin Color I | 3 Fitzpatrick Scale |
| Skin Color II | 5 Fitzpatrick Scale |
| Skin Color III | 7 Fitzpatrick Scale |
| Skin Color IV | 8 Fitzpatrick Scale |
| Skin Color V | 5 Fitzpatrick Scale |
| Skin Color VI | 1 Fitzpatrick Scale |
| Weight | 72 kilogram STANDARD_DEVIATION 13.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 1 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
None listed