N/A
N=27
Comparison of Non-Invasive Respiratory Monitoring System (RMS)
Respiratory Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT06000852 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position — 22.9 Root Mean Squared Percentage Error
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
- Michael Chu
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position |
22.9 | — |
| PRIMARY Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position |
25 | — |
| SECONDARY Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position |
.1 | — |
| SECONDARY Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position |
6.7 | — |
| SECONDARY Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position |
22.9 | — |
| SECONDARY Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position |
24.1 | — |
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 (manual counting) in healthy human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.
Participants will be asked to breath normally and according to a number of different procedure while wearing both monitors.
Eligibility Criteria
Inclusion Criteria
- Between age of 22-99
- BMI between 15 and 35 kg/m^2
Exclusion Criteria
- Medical history of serious cardiac or pulmonary diseases/conditions.
- History of serious skin irritation caused by medical adhesives (tape).
- Cannot lay still on your back for one (1) hour.
- Pregnancy.
- Unable to give written informed consent.
Data sourced from ClinicalTrials.gov (NCT06000852). 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.