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

Not Applicable

Completed

• Conditions: Respiratory Monitoring

• Registration Number: NCT06521385
• Lead Sponsor: Makani Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Status Verified: 2024-07
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Respiratory Rate Accuracy Compared Between Experimental and Reference Devices	1 hour	Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) for minute long segments.

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate Bias Compared Between Experimental and Reference Devices	1 hour	Bias of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) for minute long segments.
Makani Science System Performance after Simulated Breathing Artifacts	15 minutes	Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) after subject performed simulated breathing maneuvers.
Makani Science System Performance after Position Change	15 minutes	Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) after the subject shifts position.

Trial Locations

Locations (1)

Illumination Foundation; 🇺🇸 Fullerton, California, United States