Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes (NCT02760927), a na na study. The primary outcome is Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen.

2. Clinical Question

The clinical question is about device fit and placement, rather than a comparison of treatment effects. The stated primary outcome is the proportion of participants for whom the fastener allowed proper placement of the suction lumen. The registry describes assessment through yes/no researcher responses. It does not give the observed number of yes responses, the number of no responses, or a proportion for this endpoint. Therefore, the central outcome cannot be interpreted from the registry record.

The listed conditions are Respiratory Depression, Respiratory Failure, and Ventilatory Depression. Their presence in the record does not establish why any individual was intubated, nor does it provide details about eligibility or clinical status. Those details are not reported in the registry record. The study description identifies the device and intended tube configuration, but gives no comparative question about another holder or care approach.

3. Trial Design

The registry describes an interventional device study with a single-group model. The intervention is an endotracheal tube fastener, described as a revised commercially available holder with a tract to accommodate a subglottic suction lumen in an oral endotracheal tube. AnchorFast Guard is named in the official study title. No separate control or comparator arm is listed, and allocation is recorded as NA.

Masking is listed as NONE. The record therefore does not describe a masked design. It does not report further details about who assessed the device, whether assessments were standardized beyond the yes/no researcher response described for the primary outcome, or whether independent review was used. The phase is listed as NA. The sponsor is Hollister Incorporated.

The registry lists four participants enrolled. The study start is recorded as 2016-03, and primary completion as 2016-04. Its status is TERMINATED. The reason for termination, the timing of that decision, and whether enrollment or follow-up ended as planned are not reported in the registry record. These entries alone do not establish why the study stopped or what prompted the termination.

The primary endpoint timeframe is typical wear time of the fastener, up to one week. The registry does not describe the actual duration of exposure for individual participants, whether all participants completed that period, or how missing assessments were handled. It lists five outcome measures, but there are no analysis entries. The record does not provide a detailed protocol, a sample-size justification, a statistical analysis plan, or an explanation of whether the four enrolled participants were the intended enrollment target.

Because the study is single-group, its reported observations would describe experience with the device in the enrolled participants. Without a comparator, the design does not estimate a between-group difference. Its structure also does not support a randomized comparison. The registry record does not report an alternative design feature intended to address these limitations.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat

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: Intent-to-Treat principles followed. All four subjects were included in the analysis

6. Primary Endpoint

The registry lists the primary outcome as Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen, measured over Typical wear time of endotracheal tube fastener up to one week.

The primary endpoint is the proportion of participants on whom the test product allowed proper placement of the subglottic suction lumen. The registry defines the measurement as a count of participants and says it was assessed using yes/no researcher responses. The timeframe is typical wear time of the endotracheal tube fastener, up to one week. The stated analysis population is Intent-to-Treat.

This endpoint focuses on whether the holder can accommodate the intended tube feature in use. As a general measurement principle, a clearly defined placement outcome can make a device assessment more interpretable by specifying what researchers are judging, how they record it, and over what period. A binary response also creates a direct classification for each assessed participant: proper placement allowed or not allowed, according to the researcher response.

The registry does not report the actual responses, the count classified as yes, the count classified as no, or the resulting proportion. It also does not define additional criteria for what counted as proper placement, describe how disagreements or unclear assessments were resolved, or report whether repeated assessments were made. Those details are not reported in the registry record. Consequently, the endpoint definition can be described, but its observed result and the consistency of its measurement cannot be evaluated from this record.

The endpoint addresses a device-placement question. It is not itself a measure of respiratory outcomes, and the registry does not state that it was intended to measure those outcomes. The listed conditions do not change what this endpoint measures.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a binary primary outcome: researchers gave a yes/no response about whether the fastener allowed proper placement of the subglottic suction lumen. It labels the measure as a count of participants, sets the assessment period as typical wear time up to one week, and identifies the population as Intent-to-Treat. The record lists no analysis entries and gives no numerical primary outcome result. The statistical interpretation is therefore constrained before any question of modeling or significance: there is no posted estimate to analyze.

What does a participant proportion represent?

General statistical context: for a binary endpoint, a proportion summarizes the share of assessed participants classified in one category, such as a yes response. A count is the number of participants in a category; a proportion puts that count in relation to an applicable denominator. The denominator matters because it identifies who had an assessment and was included in the calculation. Here, the registry states that the outcome is a proportion, but it does not report the yes count, no count, assessed denominator, or calculated proportion. The enrollment count alone cannot establish how many contributed an endpoint response.

The record also does not explain the operational threshold for proper placement, how researchers were instructed to make the judgment, or whether a response could be missing or indeterminate. Those details matter to interpreting a binary classification because the recorded category depends on the measurement rule and its application. No additional measurement procedure is reported in the registry record.

What can a confidence interval add?

General statistical context: a confidence interval expresses the uncertainty associated with an estimated quantity under a stated statistical method. For a proportion, it can convey how much uncertainty remains around the observed estimate, particularly when the number of observations is limited. The interval does not remove design limitations, and it does not make a result causal. Its interpretation also depends on the data and method used to calculate it.

No confidence interval for the primary outcome is reported in the registry record, and no primary estimate is reported from which the reader could assess precision. The record also does not identify an interval method. It would therefore be inappropriate to reconstruct or infer an interval from the enrollment count.

What does the single-group design allow?

General statistical context: a single-group study can describe outcomes observed among people exposed to an intervention, provided the relevant outcome data are available. Without a comparator group, it does not estimate a relative effect against another intervention or control condition. Even a complete outcome count would answer a descriptive question about the observed group, not a randomized between-group question.

In this study, allocation is listed as NA and the model is SINGLE GROUP. No like-for-like control comparison is described. The registry also lists masking as NONE. These design features do not by themselves determine the direction or size of any outcome; they define the kinds of conclusions the design could support. Since the primary endpoint result is not posted, even a descriptive estimate is unavailable.

How should the adverse-event counts be read?

The record lists zero serious adverse events among four at risk, two other adverse events among four at risk, and zero deaths. General statistical context: adverse-event counts summarize recorded events within the stated safety categories. They are not a complete description of risk unless the event definitions, observation period, ascertainment process, and participant follow-up are also understood. The record does not identify the terms for serious events, and no top serious-event terms are listed. It does not describe the two other events, their timing, or their relationship to the device.

Counts with a small number of observed participants provide limited information about uncommon events. That is a general principle, not a claim that an unreported event occurred. The registry figures do not establish that an event could not occur, nor do they establish causation. No event-rate analysis or uncertainty interval is reported.

What can the planning assumptions tell a reader?

The record describes sample-size assumptions as a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. Such planning calculations are not the trial’s own design justification and are not observed power. The study itself is listed as single-group, so assumptions about equal allocation between two arms do not describe its recorded design.

General statistical context: a sample-size calculation is conditional on its assumptions, including the effect size chosen for planning and the analysis method. It is not evidence that a study had a particular probability of detecting an effect after the data were collected. The registry does not report a sample-size justification for this trial. Because the primary result is not reported, the planning illustration should not be treated as an observed estimate or as evidence of what the device assessment found.

No inferential test, model, adjustment, or analysis plan is reported in the registry record. The statistical methods that can be described are therefore limited to the endpoint’s stated yes/no assessment and the design information recorded in the study entry.

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.

R code and output

arm    <- c("Endotracheal Tube Fastener")
n      <- c(4)
events <- c(4)
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  Endotracheal Tube Fastener  4  4  100.0  39.8  100.0  51.0  100.0  47.8  99.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and no analysis entries. The primary endpoint is identified as the proportion of participants for whom the fastener allowed proper placement of the subglottic suction lumen. The results for that endpoint are not reported in the registry record. The record does not provide results for the other listed outcome measures in the information available for this analysis.

Multiplicity refers, in general, to the statistical issue that can arise when several outcomes or hypotheses are assessed: the chance of at least one apparently notable result can increase when many tests are conducted. Approaches to multiplicity may be prespecified, but the registry record does not report a multiplicity plan, a hierarchy among outcomes, or a correction method. With no analysis entries, it is not possible to determine whether any testing was conducted or how multiple outcomes were handled.

Missing-data methods are also not reported. The record does not state whether any primary assessments were missing, how such responses would be classified, or whether a sensitivity analysis was planned. It labels the endpoint population Intent-to-Treat, but does not describe how that population was defined or how participants without an assessment would be included. The enrollment figure does not establish the primary endpoint denominator.

These omissions limit assessment of how outcomes were selected and analyzed. They do not establish that data were missing or that a particular analysis was performed. The record also does not report a statistical analysis plan, interim analyses, or a sample-size justification. Those elements should be considered unreported rather than inferred from the available design fields.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events among four participants at risk, two other adverse events among four participants at risk, and zero deaths. The serious-event terms list is empty. These are recorded counts; they should not be interpreted as a complete account of event type, timing, severity, or cause.

The record does not describe the two other adverse events, when they occurred, or whether they were judged related to the device. It also does not provide details about how adverse events were collected, the duration of safety follow-up for each participant, or the definitions used for event categories. Those details are not reported in the registry record.

General statistical context: observing no serious events in a study does not establish that the underlying risk is zero. The strength of a safety estimate depends on how many people were observed, how long they were followed, and how consistently events were sought and classified. Counts from a small study offer limited ability to characterize uncommon events. This is a limitation of what the counts can establish, not evidence that an unreported event occurred.

The adverse-event figures do not answer the primary device-placement question. Nor do they by themselves establish whether the fastener caused or prevented any event. The registry provides no causal assessment or comparative safety analysis.

13. What the Result Does, and Does Not, Mean

The record establishes that the study was designed to assess whether a revised endotracheal tube fastener allowed proper placement of a subglottic suction lumen. It identifies a yes/no researcher assessment over typical wear time up to one week and lists four participants enrolled. It also records the study as single-group, unmasked, and terminated.

What the record does not establish is the primary outcome result. The number of yes responses, number of no responses, observed proportion, and any uncertainty interval are not reported in the registry record. Therefore, the posted information does not show how often researchers judged placement to be proper, or how precise such a result would be. No conclusion about the primary question can be drawn from the endpoint definition alone.

The study does not include a described comparator group. General statistical context: without a comparison group, observations cannot estimate how outcomes differ from an alternative holder or another care approach. Even if a descriptive result were available, the design would not support a randomized treatment-effect comparison. No such result is posted in this case.

The safety figures report zero serious adverse events among four at risk, two other adverse events among four at risk, and zero deaths. These counts are informative only as the recorded counts in this registry entry. They do not prove that the device is safe or unsafe, and the event details needed to assess relevance and causality are not reported.

The termination status does not explain why the study ended. The record does not report a reason, an interim finding, or a decision process. Termination should therefore not be interpreted as evidence for or against the device. The study’s enrollment, outcome reporting, and design each constrain interpretation; the missing primary endpoint result is the key limitation for addressing its stated clinical question.

14. Why This Trial Matters Statistically

This study raises a useful statistical distinction between defining an outcome and reporting its result. The registry gives a specific primary question: whether researchers judged that the fastener allowed proper placement of a subglottic suction lumen. It describes a binary response and a wear-time window, but the observed responses are not reported. A clear endpoint definition is important, yet it cannot substitute for the data needed to estimate the outcome.

The design also matters. A single-group device assessment can describe experience in the studied group, but does not provide a randomized comparison with a control. The record lists allocation as NA and masking as NONE. These features should shape interpretation before any statistical result is considered. Here, there is no posted primary estimate to interpret in the first place.

The enrollment count is four, while the primary endpoint denominator is not reported. This illustrates why enrollment and analysis populations are not interchangeable. A reader needs to know who was assessed, whether any assessments were unavailable, and how the endpoint was calculated. The registry labels the primary population Intent-to-Treat but does not provide further details about its implementation.

The safety counts offer another example of the difference between a count and a complete safety evaluation. The record reports zero serious adverse events among four at risk, two other adverse events among four at risk, and zero deaths. Without event descriptions, follow-up details, or comparative data, these figures have limited scope.

Statistically, this record is notable less for an estimable effect than for the limits on what can be inferred. It identifies the intended measurement and design, but does not report the primary result, analysis entries, or reason for termination. Clear reporting of denominators, outcome counts, uncertainty, and analytic decisions would be necessary for a fuller assessment.

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 principal trial-specific limitation is that the registry record does not report the primary endpoint result. It specifies the yes/no assessment and its timeframe but gives no category counts, evaluable denominator, proportion, or confidence interval. The main study question is therefore not answerable from the posted information.

Four participants are listed as enrolled, but the number assessed for the primary endpoint is not reported in the registry record. The label Intent-to-Treat does not explain who was included in the analysis or how unavailable responses were handled. Participant flow, completion of the wear period, and reasons for any missing assessments are also not reported.

The single-group design has no listed comparator, and allocation is recorded as NA. Masking is NONE. The record does not provide details about the assessment procedure, criteria for proper placement, researcher training, or how ambiguous responses were resolved. These omissions make it difficult to judge the reproducibility and potential subjectivity of the endpoint assessment.

The study is marked TERMINATED, but the reason and timing of termination are not reported. The record also does not report a trial-specific sample-size justification, statistical analysis plan, multiplicity approach, missing-data method, or interim analyses. No analysis entries are listed. These elements cannot be inferred from the study status or endpoint definition.

For safety, the record gives counts but no event descriptions for the two other adverse events, no serious-event terms, and no detail about follow-up or device relatedness. The posted counts do not support a complete safety characterization. The listed conditions and study dates provide context, but do not fill these reporting gaps.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes — NCT02760927.
• Registry record last updated 2018-09-06; status last verified 2018-08.
• Results first posted 2018-09-06.
• 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.

19. Record Summary

The registry describes a terminated, single-group device study sponsored by Hollister Incorporated. It assessed AnchorFast Guard, a revised commercially available endotracheal tube holder with a tract intended to accommodate the subglottic suction lumen of an oral endotracheal tube. The study began in 2016-03, reached primary completion in 2016-04, and lists four participants enrolled.

The primary endpoint was the proportion of participants for whom researchers reported that the fastener allowed proper placement, based on yes/no responses during typical wear time up to one week. The population is labeled Intent-to-Treat. The primary result is not reported in the registry record, and no analysis entries are listed. The reason for termination and the trial-specific statistical plan are also not reported.

The safety record lists zero serious adverse events among four at risk, two other adverse events among four at risk, and zero deaths. Event details are not reported. With no comparator and no primary outcome result, the registry record supports a description of the intended assessment and recorded safety counts, but not an estimate of the primary endpoint or a comparative conclusion.