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 Novel Airway Device to Aid Endotracheal Intubations (NCT03340207), a randomized na study. The primary outcome is Time to Intubation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03340207 |
| Phase | NA |
| Condition | Intubation Complication, Intubation;Difficult |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University at Buffalo |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing a surgical procedure under general anesthesia who require an endotracheal tube and meet the study’s inclusion criteria. The official title describes the trial as involving novice intubators, while further eligibility details are not reported in the registry record.
Intervention
PneumaGlide, a device placed in the mouth after induction of anesthesia and before intubation. The registry describes its intended role as aiding endotracheal intubation.
Comparator
No PneumaGlide insertion before intubation. Both groups underwent intubation, with the device group receiving the additional device insertion described in the registry record.
Primary question
How did the groups’ recorded times from insertion of the laryngoscope into the mouth to successful tracheal intubation compare? The registry reports median times and interquartile ranges, but no formal between-group estimate or test for this primary endpoint.
The study also describes airway difficulty grading based on visibility of the vocal cords, with grades running from full glottic visibility to visibility of neither the glottis nor epiglottis. It lists secondary outcomes concerning oxygen saturation, lip or dentition injury, requests for help, and repeated intubation attempts. These outcomes provide context about the procedure, but the central posted comparison concerns intubation time.
The registry identifies the study as randomized, with parallel groups and no masking. It records an enrollment of 32. The intended clinical question is therefore a comparison of procedural outcomes between patients assigned to device insertion and those assigned to intubation without the device; the posted record does not establish that the groups differed because of the device.
3. Trial Design
The registry describes a randomized, parallel-group study with no masking. Participants undergoing surgery under general anesthesia who required an endotracheal tube were to be screened and, if eligible, assigned to a PneumaGlide group or a non-PneumaGlide group. The device was to be placed in the mouth after induction of anesthesia. Participants in the control group did not have PneumaGlide insertion before intubation.
The registered enrollment is 32, and the posted primary outcome includes 16 participants in each group. The study is marked terminated. The reason for termination is not reported in the registry record, and the record does not describe whether termination affected recruitment, follow-up, or outcome collection. The start date is 2017-10-15 and the primary completion date is 2019-03-25.
The primary outcome is time to intubation, measured in seconds during the procedure. Timing begins when the laryngoscope is inserted into the mouth and ends when the trachea is successfully intubated. The registry specifies the median and interquartile range as the summary statistics. Airway difficulty grading based on vocal-cord visibility is also described in the primary outcome text, but no posted results for that grading measure are included in the primary results shown in the registry record.
The record lists secondary outcomes concerning oxygen saturation drop, lip or dentition injury, and requests for help and repeated intubation attempts. It also records adverse-event summaries by group. The registry lists no posted analyses, and details such as the randomization sequence, allocation concealment, protocol deviations, and analysis populations are not reported in the registry record. The record does not state why the study was terminated or provide a detailed account of the conduct of the trial.
Because the study was unmasked, participants and study personnel were not described as blinded. That feature may matter for outcomes involving procedural decisions or subjective assessment. The record does not provide further information about how intubation was performed beyond the timing definition, or about the experience and roles of the operators. Those details would help readers judge whether the trial procedures were applied consistently across groups.
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.
Before assignment: Group, age, BMI, Mallampathi class, Pre and post laryngeal grade of the airway, success and the number of attempts to intubate. As the main outcome variable, we collected the time it took to secure the airway. The occurrence of esophageal intubation, gastric aspiration, and injury to the oropharyngeal tissue was also documented.
Overall Study
| Stage | Device | Control |
|---|---|---|
| STARTED | 16 | 16 |
| COMPLETED | 16 | 16 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: time to intubate
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 | Controls | Device | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 16 | 32 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 13 | 15 | 28 |
| Age, Categorical: >=65 years | Participants | 3 | 1 | 4 |
| Age, Continuous | years | 67.6 (SD 8.6) | 65.3 (SD 7.8) | 66.7 (SD 7.0) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 16 | 16 | 32 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 3 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 13 | 13 | 26 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 3 | 6 |
| Race (NIH/OMB): White | Participants | 12 | 13 | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 16 | 16 | 32 |
| BMI | kg/m^2 | 30.0 (SD 7.6) | 32 (SD 8.4) | 31 (SD 7.5) |
| Mallampathi class | participants | 16 | 13 | 29 |
| post laryngeal grade | units on a scale | 2 (1 to 3) | 3 (1 to 3) | 2 (1 to 3) |
6. Primary Endpoint
The registry lists the primary outcome as Time to Intubation, measured over During procedure.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Seconds |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is time to intubation, recorded in seconds during the procedure. The registry defines the interval as beginning when the laryngoscope enters the mouth and ending when the trachea is successfully intubated. This captures the duration of a defined procedural task rather than a broader clinical outcome.
Time is useful for comparing procedural performance because it records how long the specified task took. In this trial, the registry chose the median and interquartile range to describe the results. The median represents the middle of the observed times, while the interquartile range describes the central spread of those observations. These summaries can be informative when times are skewed or include unusually long attempts, because the median is less affected by extreme values than the arithmetic mean.
The posted median was 56.0 seconds for Pneumaglide, with an interquartile range from 47.0 to 75.0 seconds. For non-pneumaglide, the median was 41.0 seconds, with an interquartile range from 37.0 to 48.0 seconds. These are separate group summaries; they do not, by themselves, provide a formal estimate of the between-group effect or its uncertainty.
The endpoint is procedural and does not alone describe airway difficulty, oxygenation, injury, or other aspects of safety and performance. The registry record does not report a between-group confidence interval or significance test for the primary endpoint, nor does it report a primary endpoint analysis adjusted for other variables. As a result, the posted summaries support a descriptive comparison, not a definitive statistical conclusion about the difference between groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a median time to intubation of 56.0 seconds in the Pneumaglide group, with an interquartile range of 47.0 to 75.0 seconds. The non-pneumaglide group had a median of 41.0 seconds and an interquartile range of 37.0 to 48.0 seconds. These summaries describe the observed distributions in the two groups. The registry does not report a formal comparison of these primary results, so no between-group confidence interval or p-value is available for the primary endpoint in the registry record.
The medians differ descriptively, but the information posted is not enough to determine the precision of a treatment-effect estimate or whether a statistical comparison would distinguish a group difference from sampling variability. The interquartile ranges show the spread of the central portion of each group’s observed times; they are not confidence intervals for the medians and do not directly quantify uncertainty about the difference between groups. Overlap or lack of overlap between such ranges is not a substitute for a direct statistical comparison.
The study is described as randomized, which is intended to support comparability of groups at assignment. Randomization does not eliminate chance imbalance, particularly in a small study, and the registry does not report baseline characteristics or an adjusted primary analysis. The record also does not provide details about allocation concealment, protocol deviations, or the handling of missing primary outcome data. These omissions limit assessment of how closely the posted results represent the intended randomized comparison.
The registry marks the study terminated, but the reason is not reported in the registry record. The posted primary outcome contains results for 16 participants in each group, but the record does not explain whether the planned enrollment was reached, whether all randomized participants were analyzed, or whether outcome collection was complete. It also does not give a primary endpoint analysis plan or a sample-size justification. Therefore, the reason for the observed result and the ability of the study to detect a clinically important difference cannot be determined from the registry record.
The endpoint is time to successful intubation, not a measure of every aspect of airway management. The registry describes other outcomes, including oxygen saturation drop and procedural events, but these do not replace the primary endpoint and should not be combined into an overall judgment without a prespecified analysis. The record’s secondary outcome information is limited, and no posted analyses are listed. Findings from those outcomes should therefore be interpreted cautiously and as exploratory rather than as strong confirmatory evidence.
In statistical terms, the primary result is a pair of descriptive summaries, not an estimate accompanied by an uncertainty interval or a hypothesis test. A more complete comparative report would ordinarily clarify the effect measure, its uncertainty, the analysis population, and how missing observations were handled. Since those details are not reported in the registry record, the main defensible reading is limited to the observed group medians and their interquartile ranges, without attributing the descriptive difference to the device.
9. Statistical Methods Explained
The registry records a randomized parallel-group design and identifies no masking. Randomization assigns participants to study groups using a chance-based process. In general, this helps reduce systematic differences between groups at the time of assignment, although it cannot guarantee that small groups will be balanced on every characteristic. A parallel design means participants are assigned to one group rather than receiving both study conditions in sequence. The record does not report the randomization method or allocation concealment, so the practical safeguards used to implement assignment are not described.
What does a median describe?
The median is the central value when observations are ordered. It is a way to describe a typical observation that is less influenced by unusually high or low values than the mean. The registry specifies the median for intubation time and reports the group medians as 56.0 seconds for Pneumaglide and 41.0 seconds for non-pneumaglide. Those are descriptive summaries of the recorded times, not a direct estimate of the treatment effect.
The interquartile range describes the span from the lower quartile to the upper quartile: the middle half of the observations in the ordered data. The posted ranges are 47.0 to 75.0 seconds for Pneumaglide and 37.0 to 48.0 seconds for non-pneumaglide. These ranges describe within-group dispersion. They do not show the full range of observations, and they are not confidence intervals around the medians or the difference between medians.
Why is a direct comparison important?
A statistical comparison should quantify the contrast between groups and how uncertain that estimate is. Depending on the analysis plan and the distribution of times, an analysis might compare medians or use another suitable method. General statistical practice does not identify a single method as appropriate without the analysis plan and relevant data. The registry record does not report a primary endpoint effect estimate, confidence interval, or significance test, so none can be inferred from the separate medians and interquartile ranges.
A confidence interval, in general, describes uncertainty around an estimated quantity under the assumptions of the method used. It is not the range containing a fixed proportion of individual participants’ outcomes. For this primary endpoint, a confidence interval for the between-group comparison is not reported in the registry record. The interquartile ranges should not be mistaken for such an interval. Similarly, a p-value would address compatibility of data with a specified null hypothesis under a statistical model; no primary endpoint p-value is reported.
What does randomization contribute?
In general, random assignment supports a causal comparison by reducing the risk that treatment assignment is systematically associated with participant characteristics. That reasoning depends on how assignment was implemented and on appropriate analysis of participants according to their assigned groups. The registry identifies randomization but does not report allocation concealment, an intention-to-treat analysis, or other analysis-population definitions. It is therefore not possible to verify those aspects from the registry record.
Randomization is not a guarantee against imbalance, especially when the groups are small. The primary outcome lists 16 participants in each group, but baseline characteristics are not reported in the record. Without them, it is not possible to assess whether important prognostic or procedural factors happened to differ between groups. Nor does the record say whether an adjusted analysis was planned or performed.
Why can skewness matter?
Procedural times can, in general, have an asymmetric distribution: many observations may be relatively short while a smaller number are prolonged. In that setting, a mean can be influenced by a small number of long times, while a median may provide a more robust description of the center. This is a general statistical point, not a claim about the actual distribution in this trial. The registry’s choice of median and interquartile range is consistent with reporting a center and spread without assuming that the times are normally distributed.
If a model for a mean were used with highly variable or skewed data, the model assumptions and uncertainty estimates would need attention. Over-dispersion, in general, means the observed variability is greater than a model expects; accounting for it can prevent uncertainty from being understated. The registry does not report a model for the primary endpoint, so no claim about over-dispersion or model adequacy can be made about this analysis.
What can the secondary comparison tell readers?
The registry includes a secondary outcome combining requests for help and repeated intubation attempts. Its posted comparison reports a risk difference of 0.188, with a confidence interval from -0.004 to 0.379 and an unadjusted p-value of 0.069. In general, a risk difference is the difference between the proportions experiencing an event in two groups; the interval describes uncertainty in that estimated contrast under the method used. The registry record does not identify a multiplicity adjustment for this result.
An unadjusted secondary p-value does not account for the fact that a study may assess several outcomes. When multiple hypotheses are examined, the chance of at least one apparently notable result can increase. Adjustments or a prespecified hierarchy can address that issue, but the registry record does not report whether either approach was used. Secondary results are therefore best considered supportive or exploratory unless a confirmatory analysis plan is documented.
What cannot be reconstructed?
The registry lists no posted analyses. It does not report the primary analysis method, assumptions, missing-data approach, analysis population, or whether any interim analyses were conducted. Those details are not reported in the registry record. Reconstructing a formal primary comparison from group medians and interquartile ranges alone would require individual-level information or additional distributional assumptions, neither of which is available in the record. The posted summary statistics should therefore be read descriptively, without implying an unreported test or analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a multiplicity strategy. Multiplicity arises when several outcomes or statistical comparisons are evaluated: without an adjustment or a prespecified testing hierarchy, the chance of finding at least one apparently unusual result can be higher than for a single planned test. This general concern is relevant because the record lists several secondary outcomes. It does not establish that any particular adjustment was required or used.
The record does not report a detailed statistical analysis plan, a primary hypothesis test, or a primary endpoint confidence interval. It also does not state whether secondary outcomes were prespecified in a hierarchy, whether analyses were exploratory, or whether any interim analyses were conducted. These details are not reported in the registry record, so the status of individual results as confirmatory or exploratory cannot be verified from the posted information alone.
Missing-data handling is also not reported in the registry record. The primary outcome results include 16 participants in each group, but the record does not explain whether that represents all randomized participants, whether any observations were missing, or how missing outcome measurements were treated. It does not describe withdrawals, exclusions after randomization, or sensitivity analyses. Without that information, readers cannot assess whether the analysis may have been affected by incomplete outcome data.
The record does not identify an analysis population, such as participants analyzed according to randomized assignment or only those with observed outcomes. It does not report protocol deviations or an intention-to-treat analysis. These omissions matter because analysis choices can affect comparability and interpretation, especially in a small randomized study. The record’s enrollment and posted group summaries should not be taken as proof that all planned analyses were completed or that every randomized participant contributed to every outcome.
The reason for the terminated status is not reported in the registry record. Nor is a sample-size justification or account of the study’s intended statistical power reported. Without that information, the consequences of termination for recruitment and precision remain uncertain. These gaps do not invalidate the posted descriptive results, but they constrain what can be concluded about the completeness, multiplicity, and inferential strength of 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 |
|---|---|---|---|
| Device | 0 | 16 | 0.0% |
| Control | 0 | 16 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Device | 0 of 16 |
| Control | 0 of 16 |
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 | 0 of 16 |
| Control | 0 of 16 |
The adverse-event summaries report zero serious adverse events in the device group and zero in the control group, with 16 participants at risk in each group. The record also reports zero other adverse events in each group and zero deaths in both groups. These figures describe what was posted for the recorded study groups; they are not proof that no adverse events occurred outside the registry’s definitions or reporting period.
Counts of zero can be reassuring as a description of the observed record, but they do not establish that an event is impossible or that the groups have identical risk. With a small number of participants, uncommon events may not be observed even if they can occur. A formal comparison would need an appropriate effect estimate and uncertainty interval, which are not reported for these adverse-event summaries.
The registry does not provide serious-event terms, and the reason for the terminated status is not reported in the registry record. Further details about event definitions, ascertainment, timing, severity grading, or the relationship of events to the device are not reported in the registry record. The adverse-event figures should therefore be read narrowly as the recorded counts, not as a comprehensive safety evaluation or as evidence of equivalence between groups.
12. What the Result Does, and Does Not, Mean
The posted primary endpoint describes observed intubation times in the randomized groups. The Pneumaglide group had a median of 56.0 seconds, with an interquartile range of 47.0 to 75.0 seconds; the non-pneumaglide group had a median of 41.0 seconds, with an interquartile range of 37.0 to 48.0 seconds. These summaries show how the recorded times were distributed within each group, but the registry does not provide a formal comparative analysis for this endpoint.
The result does not establish that PneumaGlide caused longer or shorter intubation times. Separate group medians are not a causal effect estimate, and the registry does not provide a confidence interval or primary p-value to quantify the uncertainty of a direct comparison. A descriptive difference can reflect a true group effect, chance variation, or other features of the trial conduct and participants. The posted record does not distinguish among these possibilities.
The result also does not establish a conclusion about every aspect of airway management. Time to successful intubation is one procedural measure. The registry lists other outcomes, including oxygen saturation drop, lip or dentition injury, and requests for help or repeated attempts, but does not provide a complete inferential analysis across them. The adverse-event summaries report zero recorded serious and other adverse events in both groups, but those counts are not enough to demonstrate equivalent safety.
Randomization is a strength of the stated design because it is intended to support comparison between assigned groups. However, the registry does not report allocation details, baseline characteristics, missing-data handling, or the analysis population. The terminated status is recorded, but the reason is not reported in the registry record. These uncertainties limit interpretation of how complete and representative the posted results are.
The most defensible meaning is therefore descriptive: the registry reports the two groups’ median intubation times and their interquartile ranges, alongside limited secondary and adverse-event information. It does not support a firm claim about the magnitude, precision, statistical significance, or clinical importance of a device effect. No medical decision should be inferred from these registry summaries alone.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the registry identifies randomization but reports the primary endpoint mainly through group summaries. Medians and interquartile ranges are useful descriptions, especially when outcome distributions may be uneven, but they do not replace a direct comparison with quantified uncertainty. Readers can see the observed group summaries without being able to assess the precision of the difference between groups from the primary result as posted.
The record also illustrates why reporting the analysis plan matters. Knowing the intended comparison, analysis population, missing-data approach, and any multiplicity strategy would help distinguish confirmatory evidence from exploratory findings. The registry does not report these details, and it lists several secondary outcomes. Without a clear analysis framework, isolated secondary results are difficult to interpret as a coherent body of evidence.
The study’s randomized design and parallel groups define a relevant comparative framework, while the unmasked status and limited posted analysis details leave important questions about conduct and interpretation. The terminated status is also material context, but the reason is not reported in the registry record. Readers cannot determine from the record whether termination influenced recruitment, completeness, or precision.
Finally, the example demonstrates the difference between a numerical contrast and an inferential conclusion. Descriptive results can be important and transparent, yet they do not alone establish causation, statistical significance, or clinical importance. A useful registry record needs both outcome values and enough methodological detail to understand how comparisons were planned and conducted. This record allows a narrow reading of the observed summaries, while leaving the strength of the primary comparison unresolved.
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 posted primary outcome is limited to a median and interquartile range in each group. A direct between-group estimate and uncertainty interval are not reported in the registry record. As a result, the descriptive contrast cannot be interpreted as a formal estimate of the device’s effect, and the precision of that contrast is unknown.
The study is marked terminated, but the reason is not reported in the registry record. The record does not explain whether recruitment stopped as planned, whether outcome collection was affected, or whether the termination changed the analysis. Although the primary results list 16 participants per group, the registry does not state whether those participants represent all randomized participants or how any missing observations were handled.
Important design and analysis details are also absent. The randomization procedure, allocation concealment, baseline characteristics, operator experience, protocol deviations, and analysis population are not reported in the registry record. The record does not provide a detailed analysis plan, a sample-size justification, or an account of interim analyses. These omissions make it harder to assess balance, potential sources of bias, and the intended precision of the study.
The study was unmasked according to the registry. Lack of masking can matter for procedural outcomes if decisions, assessments, or timing are influenced by knowledge of assignment. The record does not describe safeguards used to standardize timing or outcome assessment. The primary outcome description includes airway grading, but posted results for that grading measure are not presented in the primary result.
Secondary outcomes and adverse-event summaries provide limited additional context. The registry does not report a complete inferential analysis across the listed secondary outcomes or a multiplicity strategy. Zero recorded adverse events in the groups do not establish that risks are equal or that uncommon events cannot occur. Taken together, the record supports a descriptive account of the posted results, but leaves substantial uncertainty about analysis completeness and inferential strength.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Novel Airway Device to Aid Endotracheal Intubations — NCT03340207.
- Registry record last updated 2022-10-14; status last verified 2022-09.
- Results first posted 2022-10-14.
- 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
The registry record describes NCT03340207, a randomized, parallel-group, unmasked study of PneumaGlide for endotracheal intubation in patients undergoing surgery under general anesthesia. The registered enrollment is 32, and the study status is terminated. Its start date is 2017-10-15 and its primary completion date is 2019-03-25.
The primary endpoint is time to intubation in seconds during the procedure. The posted median is 56.0 seconds for Pneumaglide, with an interquartile range of 47.0 to 75.0 seconds, and 41.0 seconds for non-pneumaglide, with an interquartile range of 37.0 to 48.0 seconds. A formal between-group analysis for this endpoint is not reported in the registry record.
The record lists secondary procedural outcomes and reports zero serious adverse events, zero other adverse events, and zero deaths in both groups. The reason for termination, primary analysis method, missing-data approach, analysis population, and multiplicity plan are not reported in the registry record. The posted evidence is therefore descriptive and does not establish the size, precision, or clinical importance of a device effect.