Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92833
      • Illumination Foundation

Participation Criteria

Eligibility Criteria

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

Description

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.

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; Subjects with both the reference and experimental device placed for paired data collection	Device: Makani Science Respiratory Monitoring System; Subjects monitored by the Makani Science Respiratory Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate Accuracy Compared Between Experimental and Reference Devices	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate Bias Compared Between Experimental and Reference Devices	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.	1 hour
Makani Science System Performance After Simulated Breathing Artifacts	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.	15 minutes
Makani Science System Performance With Subject Laying on the 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.	15 minutes
Makani Science System Performance With Subject Laying on the 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.	15 minutes
Makani Science System Performance With Subject Laying in the Reclined 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.	15 minutes

Collaborators and Investigators

• Sponsor: Makani Science

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Makani-004

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No