Skip to main content
OpenTrials
Completed

NCT Number: NCT06521385

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Monitoring

Age range

22 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illumination Foundation

Fullerton, California, 92833, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Makani Science Respiratory Monitoring System

Device

Subjects monitored by the Makani Science Respiratory Monitoring System

Primary outcomes

  1. Respiratory Rate Accuracy Compared Between Experimental and Reference Devices

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Respiratory Rate Bias Compared Between Experimental and Reference Devices

    Time frame: 1 hour

    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.

  2. Makani Science System Performance After Simulated Breathing Artifacts

    Time frame: 15 minutes

    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.

  3. Makani Science System Performance With Subject Laying on the Right Side

    Time frame: 15 minutes

    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.

  4. Makani Science System Performance With Subject Laying on the Left Side

    Time frame: 15 minutes

    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.

  5. Makani Science System Performance With Subject Laying in the Reclined Position

    Time frame: 15 minutes

    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.

Sponsors and collaborators

Lead sponsor

Makani Science

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.