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 SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation (NCT03128931), a na na study. The primary outcome is Number of Participants For Whom the EEG Data Collection Was Completed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03128931 |
| Phase | NA |
| Condition | Anesthesia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masimo Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns pediatric patients undergoing general anesthesia or sedation. The registry lists Anesthesia as the condition and gives enrollment as 45. It does not report further eligibility details, participant characteristics, or the number who completed the EEG data collection endpoint.
Intervention
Participants in the test group received a Pediatric SedLine forehead EEG sensor. The stated purpose was to collect EEG signals with the SedLine device together with vital signs, patient demographics, anesthetic records, and surgical-procedure information. The outcome description says EEG signals were to be collected under different anesthesia and sedation conditions.
Comparator
No comparator group is described. The study is listed as single-group, with allocation recorded as NA and masking as none. It is therefore not a randomized comparison, and the test group cannot be read as one arm of a like-for-like treatment comparison. A control condition is not reported in the registry record.
Primary question
The primary endpoint asks how many participants had EEG data collection completed during the duration of surgery. This is a data-collection count, not a comparison of clinical outcomes between groups. The result for that endpoint is not reported in the registry record, so the number with completed collection cannot be stated. The record describes product-development data collection; it does not define a clinical effectiveness question or report a treatment-effect estimate.
3. Trial Design
The study is listed as a single-group device study involving pediatric patients undergoing general anesthesia or sedation. The listed device is the Pediatric SedLine forehead EEG sensor, and the only arm description says participants were enrolled in the test group and received that sensor. Allocation is recorded as NA, masking as none, and phase as NA. The record does not describe a control group or randomized allocation.
The stated purpose was to collect EEG data with the Masimo SedLine device alongside vital signs, participant demographics, the anesthetic record, and information about the surgical procedure. The primary outcome description specifies EEG signal collection under different anesthesia and sedation conditions. Its timeframe is the duration of surgery. These details indicate an engineering data-collection objective; they do not establish that the study was designed to test clinical benefit or compare alternative treatments.
The registry lists enrollment as 45. The listed start date is 2016-12-23, and the primary completion date is 2018-11-29. The study status is terminated. The reason for termination, the timing of termination relative to planned recruitment, and whether the enrollment figure represents the planned or final enrollment are not reported in the registry record. The record also does not report the protocol, recruitment flow, or any changes made to the study design.
Only one outcome measure is listed, and the record lists zero analyses. No statistical analysis plan, hypothesis-testing procedure, or estimate for the primary endpoint is reported in the registry record. Because there is no comparison group, outcome counts should be understood descriptively rather than as evidence of a difference between study arms.
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 | Test Group |
|---|---|
| STARTED | 45 |
| COMPLETED | 41 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Test Group |
|---|---|
| Physician Decision | 1 |
| Equipment Issues | 3 |
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 | Test Group |
|---|---|---|
| Participants analysed | 41 | |
| Age, Categorical: <=18 years | Participants | 41 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 32 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 |
| Region of Enrollment: United States | participants | 41 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants For Whom the EEG Data Collection Was Completed, measured over Duration of surgery.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants for whom EEG data collection was completed. Its unit is participants, and its timeframe is the duration of surgery. The endpoint description says EEG signals would be collected using the SedLine sensor during different anesthesia and sedation conditions, for product development.
A completion count can describe whether the planned signal collection was achieved for participants in a data-collection study. It is not, by itself, a measure of EEG signal quality, device accuracy, clinical benefit, or safety. Those questions would require defined measures and analyses; they are not reported in the registry record. The record does not specify operational criteria for deciding when collection counted as complete, such as required signal duration or acceptable signal quality.
The endpoint title identifies a count, but no result for the count is reported in the registry record. The enrollment figure of 45 should not be substituted for the completion count: the record does not state that all listed participants completed EEG collection. Nor does it report a breakdown by anesthesia or sedation condition, procedure, or participant characteristics. Without an outcome result and clear completion criteria, the endpoint's observed value and its precision cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry entry describes data collection in a single test group, not a controlled trial comparing the SedLine sensor with another device or with no sensor. Its primary endpoint is a participant count for completed EEG data collection during surgery. The registry record does not report the endpoint result, so there is no posted completion count to interpret. Although enrollment is listed as 45, that figure is not evidence that EEG data collection was completed for 45 participants.
The record lists 45 participants at risk in the test group for the adverse-event reporting fields, with zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. These are the posted counts, not a statistical comparison or a guarantee that no events occurred outside the reported information. The adverse-event fields do not supply event-specific details or an explanation of how safety information was collected.
No inferential analyses are listed. Consequently, the record provides no estimated effect, confidence interval, hypothesis test, or model-based assessment for the primary endpoint. A confidence interval, in general, expresses the uncertainty around an estimate under specified assumptions; without a reported endpoint estimate and analysis, that uncertainty cannot be described for this study. The data also cannot support a comparison across anesthesia or sedation conditions because such results are not reported in the registry record.
The status is terminated, but the reason and its implications for data collection are not reported in the registry record. Termination alone does not reveal whether the study stopped because of recruitment, operational, safety, technical, or other considerations. The registry lists primary completion on 2018-11-29, but that date does not supply the missing endpoint result or explain the termination status.
Overall, the posted information establishes the study's purpose, single-group design, device, enrollment figure, endpoint definition, and adverse-event counts. It does not establish how often data collection was completed, how usable the signals were, or whether device performance differed across conditions. Those conclusions require results and analytic details that are not reported in the registry record.
9. Statistical Methods Explained
This study is listed as single-group, with allocation recorded as NA and masking recorded as none. These labels describe the design as registered; they do not imply a randomized assignment or blinded assessment. In general, a comparator can help distinguish an intervention-associated pattern from changes that might occur for other reasons. No comparator is described in the registry record, so this design does not provide a between-group estimate.
The primary measure is a count of participants with completed EEG data collection. In general, a count endpoint reports how many people meet a defined condition. A count can be useful for describing completion, but interpretation depends on a clear definition of completion and a stated denominator. The registry identifies the endpoint and its timeframe as the duration of surgery, but operational completion criteria and the endpoint result are not reported in the registry record. The enrollment figure should not be treated as the endpoint count.
The record lists one outcome measure and zero analyses. It does not report a statistical analysis plan, model, hypothesis test, confidence interval, or adjustment procedure. General statistical interpretation depends on knowing what estimate was calculated, how observations were handled, and what assumptions were used. None of those analytic details can be inferred from the endpoint title alone.
For a count of participants, a descriptive report might state the number meeting the endpoint and the number assessed. That is a general explanation, not a claim about an analysis performed in this study. The record does not give the number assessed for endpoint completion or a breakdown of the count by condition. No additional count or percentage can be derived from the registry information without making assumptions about the endpoint denominator.
The sample-size planning assumptions describe an illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are assumptions for a planning illustration, not a description of this study's design: the study itself is listed as single-group and has no like-for-like control comparison. Any sample-size values based on that setup would be hypothetical planning quantities, not observed power and not evidence that the study was designed or analyzed that way. The numerical planning outputs are not reported in the registry record.
In general, statistical power is a design property evaluated for a specified effect, variability, analysis, and sample-size plan. It is not a measure of whether a study result is true, and a post hoc power calculation does not replace an estimate with an uncertainty interval. The record does not report the assumptions or analysis needed to evaluate the study's planned power. No power conclusion should be drawn from the enrollment figure alone.
Over-dispersion is a general issue for count data when observed variability exceeds what a chosen probability model expects. In that situation, a model that assumes too little variability can produce overly narrow uncertainty intervals or misleading tests. This concept does not establish that over-dispersion occurred: the primary measure is a participant count, and no fitted count model or variability estimate is reported in the registry record.
Multiplicity refers, in general, to the increased chance of false-positive findings when many hypotheses are tested without accounting for the number of tests. The record lists one outcome measure and zero analyses, and it does not report a family of statistical tests or a multiplicity adjustment. It is therefore not possible to characterize the testing strategy beyond those registry entries. One listed outcome does not, by itself, establish that no other analyses were conducted; the registry record does not report them.
Missing-data methods also matter in general. If some participants do not have an evaluable endpoint, the analysis needs to state how those participants are counted or excluded and whether the reason for missingness is described. The record does not report endpoint completeness, missing-data handling, or analysis populations. It is not possible to determine from this information whether missing endpoint data occurred.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Test Group | 41 | 41 | 100.0% | 91.4% to 100.0% | 91.4% to 100.0% | 91.6% to 99.9% |
R code and output
arm <- c("Test Group")
n <- c(41)
events <- c(41)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Test Group 41 41 100.0 91.4 100.0 91.4 100.0 91.6 99.911. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and zero analyses. It does not report a statistical analysis plan, a prespecified hierarchy of outcomes, the number of hypotheses tested, or any adjustment for multiple testing. Multiplicity methods are therefore not described in the registry record. In general, multiplicity is relevant when several outcomes, subgroups, or repeated tests are used to support conclusions; adjustment procedures can help control the chance of false-positive findings across those tests. The record does not establish whether such analyses were performed outside the registry entry.
The primary endpoint is a count of participants with completed EEG data collection, but no endpoint result or assessed-participant denominator is reported. The registry also does not state whether any participants lacked endpoint data, how incomplete recordings were classified, or how missing information was handled. These are unknowns, not evidence that data were missing or that a particular method was used.
Analysis populations are not specified. The record does not explain whether endpoint or safety summaries use all participants enrolled, participants who received the sensor, participants with available EEG data, or another defined group. The adverse-event fields list 45 at risk, but this does not define the analysis population for the primary endpoint. The registry's count of zero analyses also means no analytic population or model can be described from the posted entry.
In general, transparent reporting identifies the outcomes, analysis populations, exclusions, missing-data rules, and any multiplicity approach. Those details help readers understand which observations contribute to each result and how much reliance to place on statistical claims. For this study, these methods are not reported in the registry record, and no inferential result is available to evaluate.
12. 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 |
|---|---|---|---|
| Test Group | 0 | 45 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test Group | 0 of 45 |
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 |
|---|---|
| Test Group | 0 of 45 |
The adverse-event fields list the Test Group with 45 participants at risk for serious adverse events and 45 at risk for other adverse events. The corresponding affected counts are zero for serious adverse events and zero for other adverse events; deaths are also listed as zero. These are the reported counts in the registry entry.
These figures are descriptive. The record does not provide event terms, event timing, severity detail beyond the serious-event category, or a narrative explaining how events were monitored. No serious adverse-event terms are listed. A zero count in the posted fields should be read as no affected participants recorded in those fields, not as proof that an event was impossible or that all safety information is complete.
The registry lists enrollment as 45, and the adverse-event group lists 45 at risk. That does not establish the denominator used for the primary endpoint, nor does it show that EEG collection was completed for every participant. The record does not report a safety analysis plan or statistical comparison. As a single-group study, these counts cannot establish a relative safety difference against a control group.
13. What the Result Does, and Does Not, Mean
The record establishes that a single-group study was intended to collect pediatric EEG data with a forehead sensor during general anesthesia or sedation, together with other clinical and procedure information. It identifies a primary endpoint based on the number of participants whose EEG data collection was completed. It also reports enrollment of 45 and adverse-event counts of zero for serious events, other events, and deaths in the listed group.
The record does not report the primary endpoint result. It therefore cannot show how many participants had completed EEG collection, whether completion varied by anesthesia or sedation condition, or whether the collected signals met any quality criterion. It does not provide a measure of device accuracy, performance against another device, or clinical benefit. No comparator group or inferential analysis is reported, so a treatment or device effect cannot be estimated from this entry.
The zero adverse-event counts describe the registry's reported fields. They do not establish that the device is risk-free, and they do not support a comparative safety conclusion. The record does not provide event narratives, monitoring procedures, or a comparison group.
The study status is terminated, but the reason for termination is not reported in the registry record. The registry also does not report the statistical plan, analysis populations, endpoint completion rules, or missing-data handling. These omissions limit interpretation of both the endpoint and the safety information. The appropriate reading is narrow: the record documents a data-collection objective and a set of registered design features, while leaving the primary outcome result and most analysis details unreported.
14. Why This Trial Matters Statistically
This study is statistically distinct from a conventional randomized comparison. Its registered purpose is to collect engineering data from pediatric patients undergoing anesthesia or sedation, and it has one test group rather than a control group. That distinction matters because a single-group data-collection count answers a different question from whether one treatment performs better than another.
The primary endpoint is framed as completion of EEG data collection. That makes endpoint definition important: readers need to know what counts as completed collection and how the result is summarized. The registry identifies the unit and timeframe, but the completion criteria and result are not reported in the registry record. Without those details, the endpoint cannot be used to characterize collection success or signal usability.
The entry also illustrates why enrollment and outcome completion are not interchangeable. Enrollment is listed as 45, while the primary endpoint asks for a separate count of participants with completed EEG collection. The record does not report that count. Keeping those quantities distinct avoids treating a recruitment figure as a result.
Finally, the study is marked terminated, yet the termination reason and statistical analyses are not reported. These gaps restrict conclusions about data completeness, uncertainty, and the circumstances of the study's close. Statistically, the most useful contribution of the registry entry is to clarify the study's descriptive engineering objective and the boundaries of what its posted outcome information can support.
15. 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 primary limitation is that the registry record does not report the result for the study's only listed outcome measure. Without the number of participants for whom EEG data collection was completed, the central data-collection question cannot be answered from the posted results. The endpoint's operational definition is also not described, so it is unclear what criteria distinguished completed from incomplete collection.
The record identifies a single test group and no comparator. Consequently, it does not support a controlled estimate of differences between the device and another approach. Although EEG collection was intended across different anesthesia and sedation conditions, condition-specific outcome results are not reported in the registry record.
The analysis count is zero, and the statistical analysis plan, analysis populations, missing-data methods, and uncertainty estimates are not reported. The entry does not provide participant characteristics, recruitment flow, or details of signal quality. These omissions prevent assessment of who contributed usable endpoint data and how representative those data may be of the intended population.
The study status is terminated, but the reason for termination and its effect on data collection are not reported in the registry record. The adverse-event fields show zero affected participants in the listed categories, but event details and safety-monitoring methods are not given. These limitations mean that the posted information is best interpreted as a limited registry description, rather than a complete account of endpoint performance or safety.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation — NCT03128931.
- Registry record last updated 2022-04-07; status last verified 2022-04.
- Results first posted 2020-07-07.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry describes a single-group study of the Pediatric SedLine forehead EEG sensor in pediatric patients undergoing general anesthesia or sedation. Its stated purpose was to collect EEG data alongside vital signs, participant demographics, anesthetic records, and surgical-procedure information. The primary endpoint is the number of participants with completed EEG data collection during the duration of surgery.
Enrollment is listed as 45. The study is marked terminated; the listed start date is 2016-12-23, and the primary completion date is 2018-11-29. The registry lists one outcome measure and zero analyses. It does not report the primary endpoint result, the reason for termination, or statistical analysis details.
The adverse-event fields list 45 participants at risk, with zero serious adverse events, zero other adverse events, and zero deaths. No comparator group is described, so the record does not provide a controlled estimate of device performance or safety.