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 Assessment of an Oral Endotracheal Subglottic Tube Holder (NCT03328182), a na na study. The primary outcome is Overall Acceptability With Study Product.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03328182 |
| Phase | NA |
| Condition | Intubation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hollister Incorporated |
| Results posted | Yes |
2. Clinical Question
The study concerns the acceptability and usability of a new oral endotracheal tube holder for orally intubated patients. It evaluates experience with the device during use rather than comparing the device with a control treatment. The registry record identifies the condition as intubation and describes a single study product arm.
Population
Orally intubated patients using the study product. The registry record lists enrollment of 34, but does not provide further eligibility details or a fuller description of the population contributing to the primary outcome.
Intervention
The new oral endotracheal tube holder, identified in the record as a device. The official title names the AnchorFast Guard Subglottic ET tube assessment.
Comparator
There is no comparator arm in the registry record. The study is listed as single-group, with allocation recorded as NA.
Primary question
How acceptable was the study product during use, as rated at product removal on a five-point scale ranging from 1=Very Unacceptable to 5=Very Acceptable?
The primary outcome is described as overall acceptability relating to the general experience with the study product. Assessment was scheduled at product removal, with a maximum of 29 days of patient wearing the product. The record lists the outcome unit as participants and its parameter as a count of participants, but does not report the numerical outcome or explain how scale responses were converted into that count.
Accordingly, the registry record sets out a focused question about acceptability, but it does not provide a numerical answer from which the distribution of ratings or the strength of participants’ views can be assessed.
3. Trial Design
The record describes a completed, single-group device study sponsored by Hollister Incorporated. The listed intervention is a new oral endotracheal tube holder, and the arm description identifies a single study product arm. The study is not listed as randomized: allocation is recorded as NA, and masking is recorded as none. The record lists enrollment of 34.
The dates recorded for the study are a start date of 2017-10-23 and a primary completion date of 2018-06-08. The status is completed. Phase is recorded as NA, which is consistent with the record’s description of an assessment of a device rather than a drug-phase trial. These design details describe the registry entry; they do not establish how participants were recruited, how the device was fitted, or how use was supervised. Those details are not reported in the registry record.
A single-group design can describe experience among people who used the study product. It does not provide a concurrent control group for separating product-related effects from other influences, such as clinical setting, participant expectations, or care practices. Because masking is listed as none, the record does not describe masking of participants or study personnel. The registry record does not explain whether outcome assessors were also unmasked.
The study’s stated purpose is to assess acceptability and usability for an orally intubated patient. The primary endpoint is overall acceptability at product removal, with a maximum wearing period of 29 days. The record lists two outcome measures but zero analyses. It does not provide a numerical primary endpoint result, an analysis population, or a description of how the outcome was summarized.
These design features frame the scope of interpretation: the record describes an experience assessment in a single study product arm, not a randomized comparative trial. Its registry information is insufficient to reconstruct the conduct of the study or determine whether the enrolled participants all contributed to the reported safety and acceptability outcomes.
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 | New Oral Endotracheal Tube Holder |
|---|---|
| STARTED | 34 |
| COMPLETED | 30 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | New Oral Endotracheal Tube Holder |
|---|---|
| Withdrawal by Subject | 1 |
| Protocol Violation | 2 |
| No Product Evaluated | 1 |
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.
Population: Enrolled patients found eligible per Inclusion/Exclusion Criteria
| Characteristic | Unit | New Oral Endotracheal Tube Holder |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 52.5 (21 to 84) |
| Sex: Female, Male: Female | Participants | 13 |
| Sex: Female, Male: Male | Participants | 17 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Acceptability With Study Product, measured over At product removal (maximum 29 days of patient wearing product).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Overall Acceptability With Study Product.” It is intended to capture participants’ general experience with the product during use. The registry describes a five-point Likert scale, ranging from 1=Very Unacceptable to 5=Very Acceptable, and places assessment at product removal, with a maximum of 29 days of patient wearing the product.
A Likert response is an ordered category: the categories indicate a progression in acceptability, but the distances between adjacent categories are not necessarily equal. As a general statistical consideration, reporting the numbers of participants in each category can preserve this ordering and make the range of experience visible. A single summary can be less informative if it hides whether responses cluster at one end of the scale or are spread across categories.
The registry lists the endpoint’s unit as participants and its parameter as a count of participants. However, it does not report a result or explain which response categories, if any, were counted together. It also does not state whether the intended summary was a count in each category, a count meeting a particular acceptability threshold, or another representation of responses. No threshold should be assumed from the scale labels alone.
Acceptability is relevant to a device-use assessment because it addresses users’ experience rather than a clinical efficacy comparison. It is subjective by nature and can be affected by expectations and context, especially when masking is listed as none. Without the numerical ratings and a clear summary rule, the primary endpoint’s observed distribution and precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies overall acceptability as the primary outcome, but a numerical primary result is not reported in the registry record. As a result, the posted information does not show how participants rated the product, how ratings were distributed across the five response categories, or what count was obtained under the endpoint’s stated parameter. A direction or magnitude of acceptability cannot be inferred from the study title, purpose, or scale labels.
The study is listed as single-group, with no comparator and no masking. Its design can describe reported experience among people who used the product, but it cannot by itself establish how those experiences would differ with another holder or with another approach to tube fixation. Any observed responses could reflect the product, the circumstances of use, participant expectations, or other aspects of care. The registry entry does not report a comparative estimate that could distinguish these possibilities.
The enrollment is listed as 34. The adverse-event record separately lists 30 people at risk for serious and other adverse events. These figures refer to different registry entries; the reason for the difference is not reported in the registry record. The safety figures should therefore be read using their stated at-risk denominator, rather than assuming that the enrollment figure is the denominator for every outcome.
For serious adverse events, the record lists 3 participants affected among 30 at risk. For other adverse events, it lists 1 participant affected among 30 at risk. It also lists 1 death. These are counts, not evidence of a causal relationship to the device. The registry record does not report whether the events were judged related to the study product, how events were defined or collected, or the clinical circumstances surrounding them. The listed serious-event terms include Death, Oral Bleeding, and Loose teeth, each with a listed value of 3.3%.
No confidence interval or inferential analysis for the primary outcome is reported in the registry record. General statistical interpretation would use an estimate together with an uncertainty interval to show how precisely the data support that estimate. Without the outcome values and an analysis, neither the estimate nor its uncertainty can be assessed. A lack of a reported estimate is not evidence that acceptability was high or low; it means that the posted record does not provide the numerical result needed to make that judgment.
The record’s zero listed analyses also means it does not identify a statistical analysis of the outcomes. That does not establish what analyses may have been conducted outside the registry; such information is not reported in the registry record. The available entries support a description of the study’s stated question and design, along with the recorded safety counts, but not a conclusion about product performance or comparative benefit.
9. Statistical Methods Explained
The registry identifies the study model as single-group and the outcome type as binary, with the outcome type described as participants with an event (counts). This classification does not supply the numerical primary outcome. The primary endpoint itself is described through an ordered five-category acceptability scale, while its parameter is listed as a count of participants. Because the record does not explain how the scale was summarized into a count, it is not possible to reconstruct the intended analysis from the registry entry.
As a general statistical concept, categorical outcome summaries should make clear what each category represents and what denominator is used. For an ordered rating scale, the category frequencies can show whether responses were mostly at the favorable end, mostly at the unfavorable end, or dispersed. A combined count may be useful when a clinically or operationally meaningful threshold has been defined in advance, but the threshold and the grouping rule need to be stated. Neither is reported in the registry record. It would therefore be inappropriate to treat a particular response category as a success definition.
Counts also need a clear denominator. The record lists study enrollment of 34, while the safety entries list 30 at risk. The registry does not identify the number of participants whose primary acceptability rating was available, nor explain any difference between enrollment and the safety denominator. The endpoint’s denominator and handling of participants without a recorded rating are not reported in the registry record. Without those details, a count alone would not show the proportion of all enrolled participants with a particular rating, even if such a count were available.
There is no control arm in the listed design. In a single-group study, a descriptive estimate can characterize the observations in that group, but it does not estimate a treatment contrast. General inferential methods can quantify uncertainty around a single-group proportion or count when the outcome definition and denominator are clear. Those methods cannot supply a missing comparison group or remove potential effects of expectations and study context. The registry record does not report an inferential analysis for the primary outcome.
A confidence interval is a general statistical tool for communicating uncertainty around an estimate. Its width depends on factors including the amount of information in the data and the variability of the outcome. An interval would not correct ambiguity about the outcome definition, missing responses, or selection of participants for analysis. No primary estimate or interval is reported in the registry record, so the precision of the acceptability outcome cannot be assessed.
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These assumptions describe a hypothetical planning exercise, not the actual single-group allocation recorded for this study. The registry information does not give a numerical observed effect or numerical planning results, so the illustration cannot be evaluated as a design justification for this trial. It is not observed power and should not be read as evidence about the certainty of the trial’s findings.
The planning description distinguishes time-to-event calculations from other calculations: time-to-event tables use the total number of events under the Schoenfeld approach, while other calculations are expressed as participants per arm. That distinction is general to the stated planning display and does not mean that this device study had two randomized arms or a time-to-event primary endpoint. The listed primary outcome is an acceptability rating at product removal.
Over-dispersion is a general concern when observed variation is greater than a model assumes. In such settings, a model that treats observations as less variable than they are can understate uncertainty. The registry record does not report a model for the primary endpoint, a dispersion assessment, or an over-dispersion adjustment. The primary outcome is not numerically available, so whether this issue arose cannot be assessed. More broadly, a model choice should follow the form of the recorded outcome and the study design rather than being inferred from a generic planning assumption.
The record lists zero analyses. That entry does not specify whether descriptive summaries were prepared elsewhere, whether any model was fitted, or whether the analysis plan changed. Statistical methods, covariate adjustment, confidence intervals, hypothesis tests, and the handling of repeated or incomplete ratings are not reported in the registry record. A reader should distinguish the design information that is recorded from analyses that are not documented there.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and identifies overall acceptability as the primary outcome. It does not describe a testing hierarchy, a multiplicity adjustment, or how the other outcome measure relates to the primary question. The record also lists zero analyses. Consequently, it is not possible to determine whether formal hypothesis tests were planned or performed, or how any multiplicity was addressed. A primary-outcome label identifies the outcome of central interest in the record, but it does not establish that a particular statistical procedure was used.
Handling of missing primary outcome data is not reported in the registry record. The record does not state how many participants completed the acceptability rating, whether participants who discontinued use were included, or how an unavailable rating would be treated. It does not identify an imputation method or a sensitivity analysis. In general, missingness can affect a summary if the people with recorded outcomes differ from those without recorded outcomes; without information on completeness and handling, that possibility cannot be evaluated.
The analysis population is also not reported in the registry record. Enrollment is listed as 34, whereas the safety entries list 30 at risk. The record does not explain which participants contributed to each outcome or why the denominators differ. No assumption should be made that every enrolled participant provided an acceptability rating, or that the safety denominator defines the primary outcome population. These omissions limit assessment of both the completeness and representativeness of the reported results.
The registry record does not provide a statistical analysis plan, an account of deviations from such a plan, or the details of any interim analyses. Those matters are not reported in the registry record. Without them, the available information cannot establish how endpoint selection, missing data, or multiple outcomes were handled in the analysis.
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 |
|---|---|---|---|
| New Oral Endotracheal Tube Holder | 3 | 30 | 10.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| New Oral Endotracheal Tube Holder | 1 of 30 |
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 |
|---|---|
| New Oral Endotracheal Tube Holder | 1 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | New Oral Endotracheal Tube Holder |
|---|---|---|
| Death | Infections and infestations | 1 of 30 |
| Oral Bleeding | General disorders | 1 of 30 |
| Loose teeth | General disorders | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | New Oral Endotracheal Tube Holder |
|---|---|---|
| Skin lesion | Skin and subcutaneous tissue disorders | 1 of 30 |
Serious events with the highest arm-level rate: death (3.3%), oral bleeding (3.3%), loose teeth (3.3%).
The safety record lists one group, titled New Oral Endotracheal Tube Holder. For serious adverse events, it records 30 at risk and 3 affected. For other adverse events, it records 30 at risk and 1 affected. It separately lists 1 death. These counts should be read as the registry’s recorded safety figures, not as estimates of comparative risk, because the study has no listed control group.
The serious-event terms listed are Death, Oral Bleeding, and Loose teeth, each with a recorded value of 3.3%. The record does not provide further event narratives or explain whether a person could contribute to more than one event term. It also does not explain how the listed term percentages relate to the affected-participant count. The terms and values should therefore be reported as listed rather than combined or reinterpreted.
“At risk” is the denominator shown in the safety entry. It is not the same as the enrollment figure listed for the study, and the reason for the difference is not reported in the registry record. The record also does not state whether events were considered related to the device, how long safety follow-up lasted, or how events were elicited. The figures alone cannot establish causation, comparative safety, or the circumstances of the death. They describe what the registry records for this single study product group.
12. What the Result Does, and Does Not, Mean
The study’s registry entry identifies a practical question: how users experienced a new oral endotracheal tube holder during use. The primary endpoint is an overall acceptability rating collected at product removal, with a maximum wearing period of 29 days. This focus can be useful for describing user experience, but the numerical acceptability result is not reported in the registry record. The posted information therefore does not show whether ratings tended toward Very Acceptable, Very Unacceptable, or another point on the scale.
The design is single-group and unmasked, with no comparator arm. A descriptive account of experience in the study product arm would not, by itself, demonstrate that the product caused a particular response or that it performed better than another device. There is no like-for-like control comparison in the record. The registry also does not report enough detail about participant selection, product use, outcome completion, or analysis to assess how broadly any observed experience might apply.
The safety entries document counts of participants affected and listed serious-event terms. They are important to read as recorded safety observations, but they do not establish that the product caused the events. The registry does not report event relatedness, a comparative safety estimate, or further clinical detail. The listed death should not be assigned a cause based on the information in the record.
Statistical conclusions depend on more than a study’s stated purpose. They require a defined outcome, an observed estimate, a clear denominator, and an account of uncertainty and missing data. For this record, the primary endpoint’s numerical result, analysis population, and missing-data handling are not reported. Thus, it is not possible to quantify the observed acceptability or its precision from the registry information.
The appropriate interpretation is limited: the record documents a completed assessment intended to examine acceptability and usability, and it lists safety counts for the study product group. It does not provide the primary result or a controlled comparison. It therefore supports neither a numerical conclusion about acceptability nor a claim of comparative effectiveness or safety.
13. Why This Trial Matters Statistically
This trial is statistically notable because its stated primary question concerns a subjective, ordered rating in a single-group device assessment. Such outcomes can be informative, but their interpretation depends on how the rating categories are summarized, which participants contribute data, and how uncertainty is described. The registry record defines the scale’s endpoints and assessment timing, yet does not report the numerical result or the rule used to turn ratings into the listed participant-count parameter.
The distinction between a descriptive study and a comparative trial matters. A single-group assessment can characterize participants’ experiences, but it cannot isolate the product’s effect from expectations, care context, or other influences in the same way a suitable comparison could. The record lists no comparator and no masking. These features do not make descriptive observations meaningless; they define what kinds of conclusions those observations can support.
Denominator clarity is another important statistical issue. Enrollment is listed as 34, while the safety entries list 30 at risk. The record does not explain the difference or identify the denominator for the primary outcome. Transparent reporting of participant flow and outcome availability would help readers understand how much information supports each result and whether missing ratings could affect interpretation.
The registry includes planning assumptions for hypothetical sample-size illustrations, including a two-sided significance level of 0.05 and equal allocation between two arms. Those assumptions do not describe the listed single-group design, and the planning description is not a report of observed power. This distinction helps prevent planning calculations from being mistaken for evidence about the precision of the study’s results.
Most importantly, the primary numerical result and analysis are not reported in the registry record. The study’s purpose and design can be understood, but a statistical assessment of the central acceptability question requires the outcome values and a clear account of their analysis. This illustrates why complete outcome reporting is essential to interpreting clinical research.
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 central limitation of the registry information is that it does not report a numerical result for the primary acceptability outcome. The scale is described, but the record does not show participant ratings, a summary of those ratings, or the rule used to derive the stated participant count. Consequently, neither the observed level of acceptability nor its precision can be evaluated.
The single-group design has no comparator, and masking is recorded as none. The study can address reported experience among product users, but the record does not support a controlled comparison or a causal attribution of subjective ratings to the device. The entry does not report whether participants had prior experience with other holders or provide contextual details that might help interpret ratings.
Enrollment is listed as 34, while the safety denominator is 30 at risk. The record does not explain this difference, identify the primary outcome denominator, or describe participant flow. Missing ratings, withdrawals, and the handling of incomplete data are not reported in the registry record. This prevents assessment of whether outcome availability could have affected the results.
The registry lists two outcome measures but zero analyses. It does not report an analysis plan, a multiplicity approach, confidence intervals, or the statistical methods used for the primary endpoint. The serious-event listing lacks information on event relatedness, collection procedures, and clinical context. These gaps limit interpretation of both the acceptability and safety entries.
Finally, the sample-size assumptions describe a planning illustration with two-arm allocation, whereas the registered study model is single-group. Numerical planning results are not available in the record, and the illustration cannot establish the study’s actual precision or power. These limitations are specific to what is documented in this registry entry; additional study details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessment of an Oral Endotracheal Subglottic Tube Holder — NCT03328182.
- Registry record last updated 2019-07-05; status last verified 2019-04.
- Results first posted 2019-07-05.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group device assessment sponsored by Hollister Incorporated, with enrollment of 34. Its purpose was to assess acceptability and usability of a new oral endotracheal tube holder for orally intubated patients. Allocation is recorded as NA, masking as none, and the study status as completed.
The primary outcome is overall acceptability, rated on a five-point Likert scale at product removal, with a maximum wearing period of 29 days. The numerical primary result and the analysis are not reported in the registry record. The record lists two outcome measures and zero analyses.
For the study product group, the safety entry lists 30 at risk for serious and other adverse events, 3 affected by serious adverse events, 1 affected by other adverse events, and 1 death. The serious-event terms Death, Oral Bleeding, and Loose teeth are each listed with a value of 3.3%. Event relatedness and the reason the safety denominator differs from enrollment are not reported in the registry record.