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 (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.
Interventions
Non-invasive Respiratory Monitoring System
Sponsors
Michael Chu
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
1. Between age of 22-99 2. BMI between 15 and 35 kg/m\^2
Exclusion criteria
1. Medical history of serious cardiac or pulmonary diseases/conditions. 2. History of serious skin irritation caused by medical adhesives (tape). 3. Cannot lay still on your back for one (1) hour. 4. Pregnancy. 5. Unable to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position | 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. |
| Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position | 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. |
| Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position | 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. |
| Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position | 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. |
| Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position | 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. |
Baseline characteristics
| Characteristic | — |
|---|---|
| Abdomen Circumference | 33.1 inches STANDARD_DEVIATION 3.9 |
| Age, Continuous | 33.6 Years STANDARD_DEVIATION 12.3 |
| Body Mass Index | 24.1 kg/m^2 STANDARD_DEVIATION 3.5 |
| Height | 66.2 Inches STANDARD_DEVIATION 3.4 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 9 Participants |
| Torso Circumference | 34.2 inches STANDARD_DEVIATION 3.6 |
| Weight | 149.8 lb STANDARD_DEVIATION 24.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
None listed