This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Comparison of Non-Invasive Respiratory Monitoring System (RMS) (NCT06000852), a na phase not stated study. The primary outcome is Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06000852 |
| Phase | Phase not stated |
| Condition | Respiratory Monitoring |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Michael Chu |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned healthy human subjects. The registry record lists respiratory monitoring as the condition and records an enrollment of 27. The primary analysis population is described as subjects with a respiratory-rate measurement taken in the supine position; further eligibility and analysis-population details are not reported in the registry record.
Intervention
Participants wore the Makani Science Respiratory Monitoring System. The study description says participants were asked to breathe normally and to follow different procedures while wearing both monitors. The system was evaluated during paired measurement with a reference method, rather than as a treatment intended to change a health outcome.
Comparator
The reference was respiratory-rate measurement by manual counting performed by a trained professional. The system and manual count were measured concurrently. This is a within-participant measurement comparison, not a comparison between separately assigned device and control groups.
Primary question
For the supine position, how closely did the system's respiratory-rate measurements correspond to the trained professional's manual counts, as assessed by root mean squared percentage error? The registry record describes the measure and its confidence interval but does not report the numerical estimate. Therefore, the record does not establish from its posted results how close the two methods were or how precisely that agreement was estimated.
3. Trial Design
This completed study evaluated the Makani Science Respiratory Monitoring System in a single-group design. The registry lists enrollment of 27 and does not describe a separately assigned control arm. Its allocation entry is recorded as not applicable, and masking is listed as none. The comparison was instead made between measurements obtained concurrently from the respiratory monitoring system and manual counting by a trained professional.
The study description concerns healthy human subjects. Participants were asked to breathe normally and according to different procedures while wearing both monitors. The primary outcome focused on respiratory rate in the supine position. Secondary outcomes covered bias and precision in both supine and recline positions. The registry lists 12 outcome measures and 2 analyses, but does not provide enough information to reconstruct the full analysis plan or the relationship between every outcome and analysis.
The study start date is 2022-08-03, the primary completion date is 2022-10-29, and the status is completed. These dates describe the registry timeline; they do not provide details about how long each participant was observed beyond the primary outcome timeframe of 2 hours. Further details about procedures, the sequence of measurement conditions, participant selection, or protocol deviations are not reported in the registry record.
Because there was no separately assigned control group, the design addresses agreement between two measurement methods under the described study conditions. It does not estimate a treatment effect against usual care or a randomized control. Details of randomization are not reported in the registry record, and the allocation entry does not indicate a randomized comparison. The registry does not report a sample-size justification or enough design information to infer one.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting) |
|---|---|
| STARTED | 27 |
| Pariticpant with quiet breathing supin position | 23 |
| Participants with quiet breathing in recline position | 25 |
| COMPLETED | 26 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting) |
|---|---|
| Respiratory Monitoring System device failure | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis is done for subjects with respiratory rate measurement taken in the supine position.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Non-Invasive Respiratory Monitoring System (RMS) and Gold Standard (Manual Counting) |
|---|---|---|
| Participants analysed | 26 | |
| Age, Continuous | Years | 33.6 (SD 12.3) |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 9 |
| Race and Ethnicity Not Collected | Participants | — |
| Height | Inches | 66.2 (SD 3.4) |
| Weight | lb | 149.8 (SD 24.9) |
| Body Mass Index | kg/m^2 | 24.1 (SD 3.5) |
| Abdomen Circumference | inches | 33.1 (SD 3.9) |
| Torso Circumference | inches | 34.2 (SD 3.6) |
6. Primary Endpoint
The registry lists the primary outcome as Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position, measured over 2 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Root Mean Squared Percentage Error |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is respiratory-rate accuracy between the respiratory monitoring system and manual counting by a trained professional in the supine position. The stated measure is root mean squared percentage error (RMSE), with a 95% confidence interval. The registry describes concurrent paired measurements: for each pair, a percent difference is calculated, then the squared percent differences are averaged across the paired supine measurements for all subjects, and the square root of that average is taken.
As a general statistical concept, an RMSE combines the size of measurement discrepancies into one summary. Squaring gives larger discrepancies more influence than smaller ones, and taking the square root returns the summary to the scale of the original errors. Since the discrepancies are squared, the RMSE does not indicate whether the system tended to read higher or lower than manual counting. A separate bias measure can address direction, but the registry does not provide the primary endpoint's numerical result or a numerical bias result.
The measure is used to describe the magnitude of disagreement between the device and its reference method for the specified position. The confidence interval conveys uncertainty around the estimated RMSE; it is not a range that contains a stated proportion of individual measurement errors. The method used to calculate that interval is not reported in the registry record. Without the estimate and interval, the registry description alone cannot show the degree of agreement or its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a measurement-comparison study rather than a trial of a clinical intervention. The key statistical question is how closely the respiratory monitoring system's measurements matched concurrent manual counts by a trained professional. The primary outcome is an RMSE for percentage errors in the supine position, with a 95% confidence interval specified. However, the numerical RMSE and its interval are not reported in the registry record. The description therefore identifies what was intended to be measured, but it cannot establish the observed level of agreement or the uncertainty around it.
The primary endpoint focuses on error magnitude. Because differences are squared before averaging, larger discrepancies have a stronger influence on RMSE. The measure also combines discrepancies in either direction; it does not by itself indicate whether readings were generally higher or lower than the reference. The registry lists secondary outcomes for respiratory-rate bias and precision in supine and recline positions, but does not report their numerical findings. The labels alone cannot tell readers how bias or precision was defined or estimated.
Agreement is not the same as correlation. As a general statistical distinction, two measurement methods may change together while still differing systematically in their readings. An error-based endpoint such as RMSE directly summarizes the size of paired discrepancies, whereas a correlation alone would not answer that same question. The record's choice of RMSE is therefore directed at measurement error, but without its estimate and interval no quantitative conclusion about error is possible.
The registry lists an enrollment of 27 and describes the primary analysis population as subjects with a respiratory-rate measurement taken in the supine position. It does not report how many measurements or participants contributed to the endpoint, whether any data were excluded, or how missing measurements were handled. Enrollment should not be treated as proof that every enrolled participant contributed a usable paired measurement.
The study is single group, with a concurrent manual reference rather than a separately assigned control group. Its findings, if numerical results were available, would characterize the device-reference comparison in the described study setting; they would not by themselves establish performance in other populations or settings. The study description concerns healthy human subjects, and the registry does not report evidence for broader populations.
Accordingly, the posted record supports a description of the comparison and its intended statistical measure, not a numerical judgment about accuracy. The absence of numerical outcome findings in the registry record is consequential: neither the size of error nor the precision of its estimate can be assessed from the endpoint description alone. No conclusion about whether the device is comparable to the reference can be drawn from the posted endpoint information.
9. Statistical Methods Explained
What does the primary measure summarize?
The registry defines the primary measure as root mean squared percentage error for paired respiratory-rate measurements in the supine position. A system measurement is paired with a corresponding manual count, and a percentage difference is calculated for each pair. The squared differences are averaged, and the square root of that average produces the RMSE. This sequence produces a single summary of discrepancy magnitude across the paired observations included in the analysis.
As a general statistical explanation, squaring prevents positive and negative differences from canceling one another and gives relatively large discrepancies greater influence on the resulting summary. The square root restores the measure to the scale of the differences rather than leaving it in squared units. RMSE is therefore sensitive to occasional larger errors. It is not a summary of direction: a high or low reading contributes through its magnitude after squaring, not through a retained positive or negative sign.
What does the confidence interval convey?
The primary outcome specifies a 95% confidence interval for the RMSE. In general, a confidence interval describes uncertainty in an estimate under the assumptions of the interval method. It does not describe the spread of individual paired errors, and it is not a guarantee about any particular participant's measurement. A relatively narrow interval would indicate more precise estimation than a wider one, but the interval's numerical limits are not reported in the registry record.
The registry describes the interval's confidence level but does not report how it was calculated. Details such as the statistical procedure, assumptions, and treatment of multiple measurements from the same participant are not reported in the registry record. Those details matter because paired observations from one person may not be statistically independent. Without the method and numerical interval, readers cannot independently assess the precision estimate.
How does this differ from bias and precision?
The secondary outcome descriptions refer to respiratory-rate bias and precision for the supine and recline positions. In general, bias concerns systematic deviation in a particular direction, while precision concerns the consistency or spread of repeated measurements. These concepts are related to, but not interchangeable with, RMSE. RMSE reflects error magnitude and gives larger errors extra weight; it does not disclose the direction of the average discrepancy. The registry does not give operational definitions or numerical results for the listed bias and precision outcomes, so their exact calculations cannot be described from the record.
The use of paired concurrent measurements is pertinent to method comparison because each device reading can be considered alongside a reference reading taken at the same time. This reduces the conceptual mismatch that could arise from comparing measurements made under different conditions. The registry states that measurements were concurrent, but further procedural details, including how manual counts were conducted across the study, are not reported in the registry record.
What can be inferred from the design?
This is a single-group device evaluation, not a randomized comparison of separate intervention and control groups. The manual count serves as a reference measurement within the paired comparison. The design can address how the system's readings differ from that reference under the described measurement conditions; it does not estimate a between-group treatment effect. Allocation is listed as not applicable, and masking is listed as none. Details about blinding of the manual counter or other personnel are not reported in the registry record.
The registry describes the primary analysis population as subjects with respiratory-rate measurement taken in the supine position. It does not state the number of paired observations used, how repeated measurements were summarized for each subject, or whether the analysis accounted for clustering of observations within subjects. Those choices can affect both the estimate and its uncertainty. The stated endpoint calculation refers to paired measurements across all subjects, but does not provide further computational detail.
How should planning illustrations be understood?
Any sample-size figures associated with planning are illustrations computed from an observed effect, not evidence of the study's original design rationale. The described illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. These assumptions do not change the fact that the registry describes a single-group study. They should not be interpreted as observed power or as proof that the study was designed with those assumptions. The study's own sample-size justification is not reported in the registry record.
For time-to-event illustrations, the stated convention is a total number of events; other illustrations use participants per arm. This study's primary endpoint is an error measure, not a time-to-event endpoint. The actual planning values and the observed primary estimate are not reported in the registry record. As a general principle, planning calculations are conditional on their assumptions and should not be confused with evidence that a study can detect an effect after it has been conducted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures and 2 analyses. The primary outcome is the supine-position RMSE; the listed secondary outcomes include bias and precision for supine and recline positions. The record does not explain how all outcomes relate to the two analyses, which outcomes were tested together, or whether an order of priority was used beyond naming a primary outcome.
Multiplicity arises when several outcomes or statistical tests are considered: the chance of at least one apparently notable result can change as the number and dependence of tests change. As a general statistical principle, an analysis plan may describe how such testing is handled. Whether any multiplicity adjustment, hierarchical testing procedure, or other control was used is not reported in the registry record. No adjusted or unadjusted outcome findings are reported in the record, so no claim about their status is possible.
The primary outcome description specifies a 95% confidence interval but does not describe the interval calculation or how it fits into any broader analysis plan. The analysis plan, including any prespecified hypotheses or interim analyses, is not reported in the registry record. No interim analysis information is reported.
The registry identifies the primary population as subjects with a supine respiratory-rate measurement. It does not report a complete analysis-population definition, the amount or pattern of missing data, exclusions, or a method for handling missing measurements. It also does not report whether all enrolled participants contributed to each secondary outcome. These omissions limit assessment of selection into the analysis and the representativeness of the estimates. The enrollment figure alone does not resolve those questions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Device Arm | 0 | 27 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Device Arm | 0 of 27 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Device Arm | 0 of 27 |
The registry reports a Device Arm with 27 at risk. It records zero serious events, zero other events, and zero deaths for that group. These are the posted safety figures for the registry record; the listed serious-event terms are empty.
These counts should be read as the reported event data, not as proof that the device has no safety risks. The registry does not provide additional detail about event definitions, collection procedures, duration of safety follow-up, or whether all event types were actively sought. Nor does the record give a separate safety comparison group. Consequently, the figures do not estimate a comparative risk or establish what might occur in a different population or setting.
The study description concerns healthy human subjects and a respiratory monitoring device. Safety counts are distinct from the primary measurement-accuracy endpoint: zero reported events does not indicate how close device readings were to manual counts. Conversely, the absence of numerical accuracy findings cannot be addressed by the safety counts. Both kinds of evidence require their own interpretation, and the registry record's event figures should be considered within the limited safety information it reports.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to compare a non-invasive respiratory monitoring system with trained-professional manual counting. Its primary measure is RMSE of percentage differences for paired respiratory-rate measurements in the supine position, accompanied by a 95% confidence interval. This is a relevant form of summary for measurement error because it captures the magnitude of discrepancies and gives larger ones more influence.
The record does not report the numerical RMSE, its confidence interval, or numerical results for the secondary bias and precision outcomes. Therefore, the endpoint description cannot show how closely the methods agreed, whether one method tended to read higher or lower, or how precise any estimate was. The stated question of comparability remains unanswered by the numerical results available in the registry record.
Even a numerical agreement estimate would need to be understood in context. This was a single-group study involving healthy human subjects, and the measurement comparison used manual counting as the reference. The description does not establish how findings would extend to other populations, measurement settings, or clinical circumstances. The record also does not report sufficient detail to assess the statistical treatment of repeated measurements, missing data, or the analysis population beyond the stated supine-measurement criterion.
The study's safety record lists no serious events, other events, or deaths in the reported group. Those figures describe what was recorded in the registry; they do not establish the absence of risk or substitute for a comparative safety assessment.
Thus, the record is informative about the intended comparison, the primary accuracy metric, and the broad study structure. It is not sufficient to quantify device-reference agreement or to support a conclusion about performance. A protocol description and a completed status are not substitutes for posted outcome estimates with uncertainty.
13. Why This Trial Matters Statistically
Measurement tools can influence how a clinical variable is observed, so comparing a device with a reference method is a distinct statistical task from comparing treatments. This study's design centers on paired respiratory-rate observations: the system and a trained professional's manual count were measured concurrently. The primary endpoint, RMSE of percentage errors in the supine position, is directed at the magnitude of disagreement rather than a change in health status.
The metric also illustrates why outcome definitions matter. A single average error could conceal larger individual discrepancies or opposite-direction differences. RMSE weights larger discrepancies more heavily, while not retaining the direction of the error. The registry also lists bias and precision outcomes, which could address different aspects of measurement behavior. However, their exact definitions and numerical results are not reported in the registry record.
The design has an important interpretive boundary: it is a single-group measurement evaluation, not a randomized comparison of separate groups. Manual counting is the reference in the paired measurements, not a separately allocated control arm. That distinction affects which questions the study can answer and prevents reading the design as a treatment-effect trial.
Statistical interpretation also depends on uncertainty and analytic detail. The primary outcome calls for a 95% confidence interval, but the interval's value and calculation method are not reported. The registry lists 12 outcome measures and 2 analyses without describing multiplicity handling or the full analysis populations. Those omissions make it difficult to evaluate the evidential strength of the planned comparison from the record alone.
The study therefore matters as an example of how a device-validation question must be framed in terms of paired error, reference measurements, and uncertainty. Its registry description clarifies that framework, while the absence of numerical outcome results limits what can be concluded about the observed comparison.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation of the registry record for interpretation is that it does not report numerical results for the primary RMSE or its 95% confidence interval. Numerical findings for secondary bias and precision outcomes are also not reported. Without estimates, the size and uncertainty of the device-reference discrepancies cannot be assessed.
The study concerns healthy human subjects, so the described population does not establish applicability to other groups. The registry's description of the primary analysis population is limited to subjects with a supine respiratory-rate measurement. Additional eligibility criteria and complete analysis-population rules are not reported in the registry record.
Although the endpoint description explains how paired percentage differences contribute to RMSE, several analytic details are absent. The number of paired observations, handling of repeated measurements within subjects, treatment of missing data, exclusions, and confidence-interval method are not reported. These details are relevant to evaluating both the estimate and its precision.
The study used a single-group design and lists no masking. The registry does not report whether the person performing manual counting was blinded to system readings, or provide further information about measurement procedures that could help assess potential measurement influences. The full statistical analysis plan, multiplicity approach, and sample-size justification are not reported in the registry record.
Finally, the safety figures are limited to the event counts recorded in the registry. Details of event ascertainment and follow-up are not reported, and there is no separate safety comparison group. The reported counts therefore have a limited scope and should not be treated as a comprehensive assessment of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparison of Non-Invasive Respiratory Monitoring System (RMS) — NCT06000852.
- Registry record last updated 2026-03-25; status last verified 2023-08.
- Results first posted 2026-03-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT06000852 is a completed, single-group study titled “Comparison of Non-Invasive Respiratory Monitoring System (RMS).” The registry describes evaluation of the Makani Science Respiratory Monitoring System against manual respiratory-rate counting by a trained professional in healthy human subjects. Enrollment is recorded as 27; allocation is listed as not applicable, and masking as none.
The primary outcome is supine-position respiratory-rate accuracy measured by RMSE of percentage differences, with a stated 95% confidence interval and a timeframe of 2 hours. Secondary outcomes concern bias and precision in supine and recline positions. The registry lists 12 outcome measures and 2 analyses. Numerical outcome estimates, detailed analysis methods, missing-data handling, multiplicity procedures, and the study's sample-size justification are not reported in the registry record.
The study start date is 2022-08-03, and the primary completion date is 2022-10-29. The reported safety figures list zero serious events, zero other events, and zero deaths.