Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet (NCT00912990), a randomized na study. The primary outcome is Time to Intubation.

2. Clinical Question

The trial’s stated aims included demonstrating successful intubation in deeply sedated children without muscle relaxants and assessing whether intubation was equally effective in deeply sedated and paralyzed children. The planned comparison concerned time to intubation and adverse events. The registry’s description gives a 30 second time difference as the criterion in its aim, but it does not report an analyzed estimate of the difference or its uncertainty.

Accordingly, the clinical question is clearer than the available result. The record describes the comparison and the intended outcome, but it does not provide a primary-outcome analysis that can establish whether the groups differed or whether a clinically relevant similarity was demonstrated.

3. Trial Design

The registry describes a randomized, parallel-group trial with quadruple masking. It lists enrollment as 34 and phase as NA. The sponsor was Rady Children's Hospital, San Diego. The recorded start was 2007-01, primary completion was 2008-02, and the trial status is terminated. The reason for termination is not reported in the registry record.

The two intervention listings are cisatracurium and normal saline. The cisatracurium arm description specifies a one-time intravenous dose of 0.2mg/kg before intubation. The normal-saline volume was calculated to equal the volume of cisatracurium. The comparison is intended to distinguish intubation with muscle relaxation from intubation without it. Details such as the method used to generate the random sequence, how assignments were concealed, and which groups of people were masked are not reported in the registry record.

The registry’s brief summary describes pediatric patients with normal airways having elective surgical procedures and being deeply sedated. It does not give further information about eligibility criteria, the sedation regimen, or the conduct of intubation beyond use of the Shikani Optical Stylet. Those protocol details should not be inferred from the intervention names alone.

The primary outcome is time to intubation, defined as the time in seconds required to verify three breaths on an end-tidal carbon dioxide monitor. The registry also lists the number of adverse events as a secondary outcome. It records three outcome measures overall, but does not report a complete account of what each measure was or how each was analyzed. No analyses are listed. The registry’s primary-outcome note says that data could not be summarized or analyzed because the sample was small and technical problems with measurement made the data unreliable.

Randomization and masking describe intended protections against systematic differences and biased assessment, but they do not resolve problems with outcome measurement or missing analysis. The record does not report enough procedural detail to assess how those protections were implemented.

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

Analysis population for the primary outcome, as defined in the registry: Unable to summarize data or complete analysis due to small study sample and technical problems with measurement leading to unreliable data.

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.

6. Primary Endpoint

The registry lists the primary outcome as Time to Intubation, measured over Confirmed by the visualization of three carbon dioxide waveforms..

The primary endpoint was time to intubation. The registry defines it as the time, in seconds, required to verify three breaths on an end-tidal carbon dioxide monitor. Its timeframe is described as confirmation by visualization of three carbon dioxide waveforms. This definition ties the endpoint to an observable sign that ventilation has been established after intubation.

As a general measurement principle, a time endpoint can capture both whether a procedure reaches a specified completion point and how long it takes to get there. A consistent definition of the start and end of timing is important for a meaningful group comparison. In this trial, the registry’s endpoint definition identifies the confirmation criterion, but does not report further timing procedures, such as who measured the interval or how measurement disagreements were handled.

The registry identifies time to intubation as the primary outcome, but states that it was unable to summarize the data or complete an analysis. It attributes this to the small study sample and technical problems with measurement that made the data unreliable. No group-level time summaries, estimated difference, or uncertainty interval are reported in the registry record. As a result, the endpoint’s intended clinical meaning can be described, but the recorded information does not support a quantitative comparison of intubation times.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group design with quadruple masking. These design labels describe the intended structure of the comparison, not the quality or completeness of the outcome data. The record does not report the randomization sequence method, allocation concealment, the people included in the masking description, or a statistical analysis plan. Those implementation details cannot be inferred from the design labels.

What does randomization contribute?

General statistical context: random allocation is intended to make the groups comparable at the start of a trial, on average, with respect to both measured and unmeasured characteristics. This helps interpretation of differences that are observed after allocation. In practice, randomization does not guarantee that every characteristic will be balanced, particularly in a small trial. It also does not correct outcome-measurement errors, missing outcome data, or incomplete analysis. The registry lists enrollment as 34, but does not report a baseline comparison or the method used to assign participants.

Why is the primary outcome difficult to interpret?

The primary endpoint was time to intubation, defined through verification of three breaths on an end-tidal carbon dioxide monitor. The registry explicitly states that the data could not be summarized or analyzed because of the small study sample and technical problems with measurement that made the data unreliable. A statistical method cannot recover a trustworthy group comparison if the measurements themselves are considered unreliable. The record does not describe the technical problems in more detail or report a corrected measurement procedure.

General statistical context: an estimate describes the observed contrast between groups, while an uncertainty interval indicates the range of values compatible with the data under the model used. Wider intervals generally indicate less precision. No primary-outcome estimate or uncertainty interval is reported in the registry record, so the magnitude and precision of any time difference cannot be assessed. A p-value is also not reported for this outcome.

What would a non-significant result mean?

General statistical context: a non-significant test does not demonstrate that two groups are equivalent. It indicates that the data did not cross a specified threshold for evidence against a null hypothesis, but the result may still be compatible with meaningful differences if the estimate is imprecise. Demonstrating equivalence or non-inferiority requires a prespecified margin and an appropriate analysis of uncertainty. The brief summary refers to a non-significant difference as part of the trial’s aim and specifies a 30 second time difference, but the registry does not report an analysis using that criterion or an equivalence margin. Because no primary analysis was completed, the aim cannot be treated as a finding.

How should the adverse-event counts be read?

The registry reports event counts and numbers at risk separately for serious and other adverse events. These are descriptive counts. The record does not list an analysis, comparison estimate, uncertainty interval, or statistical method for adverse events. General statistical context: when event counts are sparse, estimates based on them can be highly uncertain, and a lack of observed serious events does not establish that the underlying risks are identical or absent. A formal comparison would need to account for the limited information and the trial’s ascertainment and follow-up procedures, which are not described in the registry record.

What do the planning assumptions represent?

The stated sample-size assumptions describe planning illustrations based on an observed effect, not the trial’s own design calculation. They specify a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. General statistical context: a planning illustration estimates the sample size that might be needed under stated assumptions. It is not an observed result and is not observed power. Such an illustration does not show that the original trial was designed with those assumptions. The registry record does not report the trial’s own sample-size justification or protocol planning assumptions.

The record lists no analyses. It does not report whether there were interim analyses, how missing data were handled, or whether the analysis population followed assignment as randomized. These omissions limit assessment of the analysis process and are distinct from the stated problem of unreliable primary-outcome measurement.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and identifies time to intubation as the primary outcome, with the number of adverse events listed as a secondary outcome. It does not give a complete account of the outcome measures, analysis methods, or planned comparisons. No analyses are listed. The primary-outcome note says that an analysis could not be completed because the sample was small and technical measurement problems made the data unreliable.

When a trial assesses multiple outcomes or comparisons, multiplicity can increase the chance of a seemingly notable result arising by chance. General statistical context: researchers may address this through a prespecified hierarchy, adjustment, or a clear distinction between primary and exploratory analyses. The registry does not report whether any multiplicity approach was planned or used. It would therefore be inappropriate to assume an adjustment, or to infer that the reported adverse-event counts were tested as a formal comparison.

Missing-data procedures and analysis populations are also not described. The registry does not report how participants with missing or unusable measurements were handled, whether all randomized participants were included in any analysis, or whether analyses followed assigned groups. The statement that the primary data could not be summarized or analyzed is the available explanation; further reasons or handling decisions are not reported in the registry record.

Interim analyses, stopping rules, and a statistical analysis plan are not reported in the registry record. The terminated status does not by itself explain whether any such procedures were used or why the trial ended. These gaps prevent a fuller assessment of selective reporting, analysis decisions, and the relationship between intended and completed analyses.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry records serious and other adverse events by intervention group. For cisatracurium, it reports 0 serious adverse events among 16 at risk and 0 other adverse events among 16 at risk. For normal saline, it reports 0 serious adverse events among 18 at risk and 3 other adverse events among 18 at risk. The registry lists no serious adverse-event terms. Death counts are not reported in the registry record.

These are event counts, not estimates of comparative risk. The record does not report a statistical analysis, uncertainty interval, or a formal group comparison for these outcomes. A count of zero means no event of that category was recorded in the listed group; it does not establish that the underlying event risk is zero. Likewise, the count of 3 other adverse events in the normal-saline group does not by itself show that the group had a higher risk.

The registry does not report additional details about event definitions, ascertainment, timing, or follow-up. The adverse-event figures therefore describe what was recorded, but should be interpreted cautiously and separately from the unavailable primary-outcome analysis.

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

The record describes a randomized comparison of cisatracurium and normal saline for pediatric elective intubation using the Shikani Optical Stylet. Its intended question concerned intubation time and adverse events, including whether intubation could be assessed as similarly effective with and without muscle relaxation. The registry does not report an analyzable primary-outcome result, so it does not establish the size or direction of a difference in intubation time.

The stated aim’s reference to a non-significant difference is not a result. The registry says the time data could not be summarized or analyzed because the study sample was small and technical measurement problems made the data unreliable. Without an estimate and its precision, readers cannot determine whether the data are compatible with no difference, a small difference, or a larger difference. The stated 30 second criterion cannot be evaluated from the posted primary-outcome information.

The adverse-event figures report no serious events in either group, and report 3 other events in the normal-saline group and 0 in the cisatracurium group. These descriptive counts do not establish equivalence or a reliable difference in safety. The registry does not report inferential results for these outcomes, and death counts are not reported in the registry record.

More generally, an unavailable or unreliable outcome analysis is not evidence that the interventions are the same, nor is it evidence that one is better. Randomization and masking are features of the design; they do not substitute for trustworthy measurements and completed analysis. The record supports a description of the trial’s stated question, design, endpoint definition, and adverse-event counts, but it does not support a conclusion about comparative effectiveness.

The trial is listed as terminated, but the reason for termination is not reported. The record also does not provide the statistical plan, detailed analysis populations, or methods for handling missing data. Those omissions limit interpretation of how the study was intended to produce a result and why the primary outcome remained unanalyzed.

13. Why This Trial Matters Statistically

This trial illustrates a distinction that matters in clinical research: a clearly stated question and randomized design do not guarantee an interpretable estimate. The registry identifies a comparison of cisatracurium with normal saline and defines a primary endpoint, but it also states that technical measurement problems made the primary data unreliable and prevented analysis. Measurement quality is therefore central to interpretation, not a minor detail that can be resolved by choosing a more sophisticated statistical test.

The trial also highlights the difference between testing for a difference and demonstrating equivalence. Its brief summary describes an aim of equal effectiveness and refers to a non-significant difference, alongside a 30 second criterion for time to intubation. Those aims require an analysis capable of assessing the relevant margin with adequate precision. Because the registry reports no primary analysis, it is not possible to determine whether the intended criterion was met. More generally, failure to detect a difference is not proof that outcomes are sufficiently similar.

The adverse-event record offers another useful statistical lesson. Zero recorded serious events in both groups is a descriptive observation, not proof of zero risk or matching safety. Counts must be interpreted in the context of the amount and quality of follow-up, event definitions, and uncertainty. These details are not reported in the registry record.

Finally, the terminated status and absence of listed analyses leave important questions unanswered about the study’s completion and analysis process. The reason for termination is not reported. The record is a reminder that registry entries can document design intentions and selected results while still leaving the primary comparative question 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 most direct limitation is the registry’s statement that the primary endpoint could not be summarized or analyzed. The stated reasons are the small study sample and technical problems with measurement that made the data unreliable. No group-level time results or measure of uncertainty are reported. This prevents assessment of the primary comparison and of the stated 30 second criterion.

The registry does not describe the measurement problems in detail. It does not report when timing began, who recorded it, whether measurement procedures changed, or whether any validation or correction was attempted. Without those details, the extent and direction of possible measurement error cannot be assessed.

The record’s design information is also limited. Although the trial is described as randomized and quadruple masked, the method of random sequence generation, allocation concealment, and identities of those masked are not reported. Further eligibility details, sedation procedures, and intubation procedures are likewise not reported in the registry record. These limitations concern the ability to assess trial conduct; they do not establish that any particular procedure was inadequate.

Adverse-event information is limited to the recorded counts and at-risk numbers. Definitions, ascertainment procedures, follow-up duration, and analyses are not reported. Death counts are not reported in the registry record. The sparse event counts do not permit a confident comparative safety conclusion.

The registry lists three outcome measures but does not provide a complete account of them or their analyses, and it lists no analyses. A statistical analysis plan, missing-data procedures, analysis populations, interim analyses, and the reason for termination are not reported. These gaps limit assessment of how outcomes were selected and analyzed. The record should therefore be read as an incomplete account of the intended comparison, rather than as a completed evaluation of the primary clinical question.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet — NCT00912990.
• Registry record last updated 2020-08-18; status last verified 2020-08.
• Results first posted 2020-08-12.
• 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.

18. Record Summary

The registry describes NCT00912990 as a randomized, parallel-group, quadruple-masked trial with enrollment listed as 34. It compares cisatracurium, described as a one-time intravenous dose of 0.2mg/kg, with normal saline of equal volume for pediatric elective intubation using the Shikani Optical Stylet. The recorded start was 2007-01, primary completion was 2008-02, and status is terminated. The reason for termination is not reported in the registry record.

The primary endpoint was time to intubation, defined by verification of three breaths on an end-tidal carbon dioxide monitor. The registry states that the primary data could not be summarized or analyzed because the sample was small and technical problems made measurement unreliable. Adverse-event counts are recorded, but no statistical analyses are listed. The posted record therefore describes the trial’s design and limited safety counts without resolving its primary comparative question.