N/A
N=32
Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
Respiratory Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT06521385 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Respiratory Rate Accuracy Compared Between Experimental and Reference Devices — .63 Breath Per Minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Makani Science Respiratory Monitoring System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Makani Science
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Rate Accuracy Compared Between Experimental and Reference Devices |
.63 | — |
| SECONDARY Respiratory Rate Bias Compared Between Experimental and Reference Devices |
-.40 | — |
| SECONDARY Makani Science System Performance After Simulated Breathing Artifacts |
.57; -.38 | — |
| SECONDARY Makani Science System Performance With Subject Laying on the Right Side |
.67; -.67 | — |
| SECONDARY Makani Science System Performance With Subject Laying on the Left Side |
1.49; -1.49 | — |
| SECONDARY Makani Science System Performance With Subject Laying in the Reclined Position |
1.38; -1.25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06521385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.