Comparison of Non-Invasive Respiratory Monitoring System (RMS)

NCT06000852 | Completed Results

• 1 other identifier: MAKANI-002
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position

  2 hours

• Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position

  2 hours

• Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position

  2 hours

• Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position

  2 hours

Other Outcomes (6)

• Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Supine Position

  2 hours

• Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Recline Position

  2 hours

• Subgroup Analysis Results of Respiration Rate Bias by BMI for Supine Position

  2 hours

Study Arms (1)

Device Arm

EXPERIMENTAL

Device: Makani Science Respiratory Monitoring System

Interventions

Makani Science Respiratory Monitoring System DEVICE

Non-invasive Respiratory Monitoring System

Device Arm

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between age of 22-99
• BMI between 15 and 35 kg/m\^2

You may not qualify if:

• Medical history of serious cardiac or pulmonary diseases/conditions.
• History of serious skin irritation caused by medical adhesives (tape).
• Cannot lay still on your back for one (1) hour.
• Pregnancy.
• Unable to give written informed consent.

Sponsors & Collaborators

• Michael Chu: lead

Results Point of Contact

• Title: Michael Chu
• Organization: Makani Science

michael@makaniscience.com

408 992 1882

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: August 3, 2022
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2022
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share