Comparison of Non-Invasive Respiratory Monitoring System (RMS)

Makani Science Respiration Monitoring System Pivotal Clinical Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Monitoring
• Intervention / Treatment: Device: Makani Science Respiratory Monitoring System

• Study Type: Interventional
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Arm	Device: Makani Science Respiratory Monitoring System; Non-invasive Respiratory Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Michael Chu

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): October 29, 2022
• Study Completion (Actual): October 29, 2022

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MAKANI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO