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

Makani Science

Status: Completed

Conditions: Respiratory Monitoring

Treatments: Device: Makani Science Respiratory Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06521385

Makani-004

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 22 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Device Arm

Experimental group

Description:

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

Treatment:

Device: Makani Science Respiratory Monitoring System