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

NCT06521385 | Completed Results FDA Device

• 1 other identifier: Makani-004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Respiratory Rate Bias Compared Between Experimental and Reference Devices

  1 hour

• Makani Science System Performance After Simulated Breathing Artifacts

  15 minutes

• Makani Science System Performance With Subject Laying on the Right Side

  15 minutes

• Makani Science System Performance With Subject Laying on the Left Side

  15 minutes

• Makani Science System Performance With Subject Laying in the Reclined Position

  15 minutes

Study Arms (1)

Device Arm

EXPERIMENTAL

Subjects with both the reference and experimental device placed for paired data collection

Device: Makani Science Respiratory Monitoring System

Interventions

Makani Science Respiratory Monitoring System DEVICE

Subjects monitored by the Makani Science 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 40 kg/m\^2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makani Science: lead

Study Sites (1)

Illumination Foundation

Fullerton, California, 92833, United States

Location

Results Point of Contact

• Title: Dr. Michael Chu
• Organization: Makani Science

michael@makaniscience.com

(949) 427-5208

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: May 17, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)