Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Respiratory Rate Accuracy Compared Between Experimental and Reference Devices
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Device Arm
Subjects with both the reference and experimental device placed for paired data collection
Intervention: Makani Science Respiratory Monitoring System (Device)
Outcomes
Primary Outcomes
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
- 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)