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 Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies (NCT02038894), a randomized na study. The primary outcome is Number of Participants With Respiratory Complications.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02038894 |
| Phase | NA |
| Condition | Eosinophilic Esophagitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 179 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Results posted | Yes |
2. Clinical Question
Population
Children undergoing esophagogastroduodenoscopy (EGD) are the population of interest. Eosinophilic esophagitis is listed as a condition in the registry record. The primary outcome timeframe runs from admission for surgery through the recovery period, approximately 3 hours. Further eligibility details and a more specific description of the analyzed population are not reported in the registry record.
Intervention
The record describes anesthetic techniques that include intubation with sevoflurane and intubation with propofol. It also lists a no-intubation technique. The intervention list names “Zofran - no intubation” and “Propofol,” while the arm descriptions identify “Native Airway - no intubation” as the third technique. The relationship between these labels is not explained in the registry record.
Comparator
The three anesthetic groups are compared with one another. The stated aim is to assess respiratory complications while considering techniques used during EGD. The registry description notes that the techniques were in use at Cincinnati Children's Hospital Medical Center and that anesthesiologists selected techniques based on clinical preference and experience before the study.
Primary question
The primary outcome is the number of participants with respiratory complications during admission for surgery through recovery, approximately 3 hours. The registry description proposes a chi-square test or Fisher's exact test to measure differences among the three anesthetic groups. The primary outcome results, the test used, and the resulting statistical comparison are not reported in the registry record. The available adverse-event counts should not be treated as a substitute for that missing primary-outcome comparison.
3. Trial Design
The registry record describes a randomized, parallel-group trial with single masking. It lists an enrollment of 179 and a completed status. The study start is recorded as 2009-12, and primary completion as 2013-11. The sponsor is Children's Hospital Medical Center, Cincinnati. The phase is listed as NA.
The planned comparison concerns three anesthetic techniques for children undergoing EGD: intubation with sevoflurane, intubation with propofol, and a native airway without intubation. The arm descriptions use those three categories. The interventions list, however, includes “Zofran - no intubation” and “Propofol,” and does not use exactly the same wording as the arm descriptions. The registry record does not clarify the relationship between these entries, so the arm descriptions are the clearest basis for describing the three comparison groups.
Random allocation means that assignment to the study groups was intended to be determined by chance, rather than solely by clinician preference. This design can support a fairer comparison by reducing systematic differences between groups at the outset, although randomization does not guarantee that every relevant characteristic will be balanced. The allocation method, concealment procedures, and details of the single masking are not reported in the registry record. In particular, the record does not identify who was masked.
The main outcome concerns respiratory complications from admission through recovery, with the timeframe described as approximately 3 hours. Peri-operative times between the three techniques are listed as a secondary outcome. Further details about the conduct of the trial, deviations from assigned techniques, and analysis populations are not reported in the registry record.
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 | Intubated With Sevoflurane (IS) | Intubated With Propofol (IP) | Native Airway - no Intubation |
|---|---|---|---|
| STARTED | 60 | 58 | 61 |
| COMPLETED | 60 | 58 | 61 |
| NOT COMPLETED | 0 | 0 | 0 |
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 | Intubated With Sevoflurane (IS) | Intubated With Propofol (IP) | Native Airway - no Intubation | Total |
|---|---|---|---|---|---|
| Participants analysed | 60 | 58 | 61 | 179 | |
| Age, Continuous | years | 8 (4 to 10) | 6 (4 to 9) | 7 (4 to 10) | 7 (4 to 10) |
| Sex: Female, Male: Female | Participants | 27 | 25 | 26 | 78 |
| Sex: Female, Male: Male | Participants | 33 | 33 | 35 | 101 |
| Race/Ethnicity, Customized: African American | Participants | 4 | 2 | 2 | 8 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 1 | 1 | 3 |
| Race/Ethnicity, Customized: Caucasian | Participants | 55 | 52 | 51 | 158 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 2 | 6 | 8 |
| Race/Ethnicity, Customized: Unknown | Participants | 0 | 1 | 1 | 2 |
| Region of Enrollment: United States | Participants | 60 | 58 | 61 | 179 |
| Weight | kg | 25 (15.9 to 35.8) | 22.7 (17.8 to 31.8) | 22.5 (16.5 to 37.7) | 24.3 (16.4 to 35.3) |
| BMI | kg/m^2 | 16 (14.9 to 17.9) | 16.1 (14.8 to 17.4) | 16.6 (15.3 to 18.4) | 16.4 (15 to 17.9) |
| BMI Percent | percentile | 46 (21.6 to 78.2) | 57.1 (24.6 to 76.9) | 67 (39.9 to 83.7) | 56.8 (25.3 to 81.7) |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition): ASA 1 (Normal healthy subject) | Participants | 13 | 15 | 10 | 38 |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition): ASA 2 (Mild systemic disease) | Participants | 47 | 43 | 50 | 140 |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition): Missing or Unknown | Participants | 0 | 0 | 1 | 1 |
| Diagnosis: Abdominal Pain | Participants | 15 | 20 | 15 | 50 |
| Diagnosis: Chronic Diarrhea | Participants | 3 | 3 | 1 | 7 |
| Diagnosis: Diarrhea | Participants | 1 | 1 | 0 | 2 |
| Diagnosis: Dysphagia | Participants | 4 | 3 | 0 | 7 |
| Diagnosis: Eosinophilic esophagitis | Participants | 18 | 10 | 24 | 52 |
| Diagnosis: Failure to Thrive | Participants | 5 | 3 | 5 | 13 |
| Diagnosis: Feeding Difficulties | Participants | 2 | 1 | 0 | 3 |
| Diagnosis: GERD | Participants | 6 | 5 | 8 | 19 |
| Diagnosis: Nausea/Vomit | Participants | 4 | 9 | 7 | 20 |
| Diagnosis: Rumination Syndrome | Participants | 0 | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Respiratory Complications, measured over Admission for surgery through recovery period, approximately 3 hours.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with respiratory complications during the period from admission for surgery through recovery, approximately 3 hours. It is a participant-count outcome: the stated measure concerns whether participants experienced the outcome, rather than the duration or severity of each event. The registry description says the purpose is to assess the balance between a safe anesthetic technique with a minimal incidence of respiratory complications and a technique that facilitates rapid turnover of the gastrointestinal suite.
For a binary endpoint, each participant is classified according to whether the specified event occurred during the defined observation period. Comparing the number of participants with an event across groups can help assess whether event occurrence differs among the anesthetic techniques. The registry description names a chi-square test or Fisher's exact test as possible methods for measuring differences among the groups. The primary endpoint results and the precise event definition used for analysis are not reported in the registry record.
General statistical context: a clearly defined observation window matters because events outside it do not count toward that endpoint unless the protocol specifies otherwise. The record gives an approximate timeframe, but does not report detailed rules for classifying respiratory events, handling repeated events in one participant, or resolving uncertain cases.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a clinically focused comparison of three anesthetic approaches for pediatric EGD, with respiratory complications as the primary outcome. Its description frames the question as a balance between respiratory safety and efficient turnover of the gastrointestinal suite. The proposed comparison is among intubation with sevoflurane, intubation with propofol, and a native airway without intubation.
The record does not report the primary outcome counts by group, an effect estimate, a confidence interval, a p-value, or which statistical test was ultimately used. Consequently, the posted information does not establish the direction or size of any difference in the primary endpoint, nor how precisely such a difference was estimated. The adverse-event counts do not fill this gap: those counts are reported in separate serious and other adverse-event categories, and the registry does not identify them as the primary endpoint analysis.
For adverse events, the registry lists serious-event counts of 0 among 60 participants at risk in the sevoflurane-intubation group, 1 among 58 in the propofol-intubation group, and 14 among 61 in the native-airway group. It also lists other adverse-event counts of 1 among 60, 4 among 58, and 24 among 61, respectively. These are descriptive entries. The record does not provide a statistical comparison for these figures, and it does not explain whether event categories overlap or how events were classified. They therefore should not be read as a tested estimate of the primary outcome.
General statistical context: event counts can be informative, but their interpretation depends on the endpoint definition, observation period, completeness of follow-up, and the number of participants contributing data. A confidence interval, when reported, describes the uncertainty around an estimated effect under the analysis assumptions; it does not by itself establish clinical importance. A p-value addresses compatibility with a specified statistical model and null hypothesis, but is not a measure of effect size. Neither type of primary-outcome result is reported in the registry record.
The record's enrollment figure and randomized design describe the study setup, not the precision of its primary-outcome estimate. Without the primary results and analysis details, the available information supports describing the comparison and its reported adverse-event entries, but not drawing a conclusion about comparative respiratory-complication risk.
9. Statistical Methods Explained
The registry description says that a chi-square test or Fisher's exact test would measure differences among the three anesthetic groups for the primary outcome. It does not report which test was used, whether the analysis followed the proposed approach, or what result the analysis produced. The following explains these methods generally; it is not a claim about an analysis actually conducted for this trial.
How does a chi-square test apply?
General explanation: a chi-square test can compare the distribution of a categorical outcome across groups. For a binary participant outcome, the data can be organized by group and by whether the event occurred. The test assesses whether the observed pattern of event and non-event counts is compatible with a common event distribution across groups. It does not, on its own, state which groups differ or quantify the size of a particular pairwise difference. Those questions require estimates and, where appropriate, follow-up comparisons.
The method relies on an approximation that works best when expected cell counts are not too small. If some event categories are sparse, the approximation may be unreliable. The registry description explicitly allows Fisher's exact test as an alternative. General explanation: Fisher's exact test calculates the probability of patterns at least as extreme as the observed one under a specified null hypothesis, conditional on the margins of the contingency table. It is often considered when counts are small, but the registry record does not say whether sparse counts occurred or which test was selected.
What would an effect estimate add?
General explanation: an overall test can indicate whether the data are inconsistent with a hypothesis of no group difference, but it does not describe the magnitude or precision of the differences. Group-specific event counts, an effect measure, and a confidence interval would help readers assess the pattern and uncertainty. The registry record does not report primary-outcome group counts or an effect estimate and confidence interval. No primary-outcome p-value is reported either. Without those results, the planned test cannot be interpreted as a finding.
A confidence interval is a range of values produced by a statistical procedure that, under its assumptions, conveys uncertainty around an estimate. Its width depends on factors including the amount of information in the data and the variability of the outcome. General explanation: a wide interval indicates less precision than a narrow interval, while an interval's clinical relevance depends on the values it includes and the importance of the outcome. There is no primary-outcome interval in the registry record to assess.
What is the role of randomization?
General explanation: random assignment is intended to make treatment groups comparable on average with respect to both measured and unmeasured characteristics. In a particular trial, chance imbalances may still occur, especially for characteristics that strongly predict the outcome. Randomization does not address errors in outcome measurement, missing outcome data, or departures from assigned treatment. The registry record identifies the allocation as randomized but does not report the sequence-generation method, allocation concealment, or a baseline comparison suitable for evaluating the groups.
The parallel-group design means participants are assigned to one study group rather than receiving each technique in a crossover sequence. In general, an analysis should reflect the assigned groups and the study's prespecified approach, but the analysis population and handling of any crossover or nonadherence are not reported in the registry record. The masking classification is single; who was masked and how masking was maintained are not reported.
What can the adverse-event counts tell readers?
The posted serious adverse-event entries are counts with participants at risk: 0 among 60 for intubated sevoflurane, 1 among 58 for intubated propofol, and 14 among 61 for native airway without intubation. Other adverse-event counts are 1 among 60, 4 among 58, and 24 among 61, respectively. General explanation: raw counts are descriptive, and comparisons require attention to the event definitions, observation period, completeness of reporting, and uncertainty. These entries do not supply an inferential test or an adjusted comparison. The record does not establish that these adverse-event categories are identical to the primary respiratory-complication endpoint.
The record also lists severe desaturation, described as SpO2 < 85%, at 14.8%, and apnea at 8.2%, among the top serious terms. Their denominators and relationship to the group-level counts are not reported in the registry record. They should therefore be read as reported term percentages, not converted into group counts or assigned to a particular arm.
The sample-size assumptions describe 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. The illustration is not the trial's own design justification. General explanation: a planning calculation asks what sample size might be needed for a specified effect and assumptions; it is not observed power and cannot replace a confidence interval for the results actually obtained. Specific planning outputs and the trial's sample-size justification are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The trial compares three anesthetic groups, and the registry lists a primary respiratory-complication outcome plus peri-operative times as a secondary outcome. The registry record reports two outcome measures and three analyses, but does not explain how those analyses map to outcomes, groups, or time points. It does not report a prespecified strategy for controlling multiplicity, such as prioritizing comparisons or adjusting significance thresholds.
General statistical context: when several outcomes, time points, or pairwise comparisons are examined, the chance of obtaining an apparently unusual result by chance can increase if each is treated as a separate test. A prespecified analysis plan can clarify which comparison is primary and how secondary or exploratory analyses should be interpreted. Since the analysis plan is not reported in the registry record, the role of multiplicity control cannot be assessed.
The primary outcome timeframe is described as admission through recovery, approximately 3 hours, but detailed missing-data rules are not reported in the registry record. The record does not state how participants with incomplete outcome assessment were handled, whether any outcomes were missing, or whether sensitivity analyses were performed. It also does not identify the analysis population, such as whether the primary comparison included all randomized participants or another defined group.
These omissions matter because missing outcomes and analysis-population choices can affect both the estimated event pattern and its uncertainty. The registry record does not report an account of exclusions after randomization, protocol deviations, or the handling of participants who did not receive their assigned technique. No conclusion about the effect of missing data or multiplicity can be drawn from the available record.
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 |
|---|---|---|---|
| Intubated With Sevoflurane (IS) | 0 | 60 | 0.0% |
| Intubated With Propofol (IP) | 1 | 58 | 1.7% |
| Native Airway - no Intubation | 14 | 61 | 23.0% |
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 |
|---|---|
| Intubated With Sevoflurane (IS) | 1 of 60 |
| Intubated With Propofol (IP) | 4 of 58 |
| Native Airway - no Intubation | 24 of 61 |
Most frequent serious adverse event terms
| Event term | Organ system | Intubated With Sevoflurane (IS) | Intubated With Propofol (IP) | Native Airway - no Intubation |
|---|---|---|---|---|
| Severe desaturation: SpO2 < 85% | Respiratory, thoracic and mediastinal disorders | 0 of 60 | 0 of 58 | 9 of 61 |
| Apnea | Respiratory, thoracic and mediastinal disorders | 0 of 60 | 1 of 58 | 5 of 61 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intubated With Sevoflurane (IS) | Intubated With Propofol (IP) | Native Airway - no Intubation |
|---|---|---|---|---|
| Minor desaturation < 95% | Respiratory, thoracic and mediastinal disorders | 0 of 60 | 0 of 58 | 15 of 61 |
| Inadequate anesthesia | Surgical and medical procedures | 1 of 60 | 4 of 58 | 9 of 61 |
Serious events with the highest arm-level rate: severe desaturation: spo2 < 85% (14.8%), apnea (8.2%).
The registry lists serious adverse-event entries by anesthetic group. For intubation with sevoflurane, the serious-event count is 0 among 60 participants at risk; for intubation with propofol, it is 1 among 58; and for native airway without intubation, it is 14 among 61. The other adverse-event counts are 1 among 60, 4 among 58, and 24 among 61, respectively. These are separate reported categories, and the registry record does not explain whether a participant could contribute to more than one category.
The top serious terms are severe desaturation, listed as SpO2 < 85%, at 14.8%, and apnea at 8.2%. The record does not report the denominators for these term percentages or how they relate to the group-level entries. Death counts are not reported in the registry record.
These figures are descriptive safety information, not a statistical comparison. The registry record does not supply confidence intervals, p-values, adjustment methods, or detailed event-classification rules for these entries. Nor does it establish that the adverse-event categories correspond exactly to the primary respiratory-complication endpoint. Counts should therefore be interpreted within their reported categories and not as proof of a causal difference between techniques.
12. What the Result Does, and Does Not, Mean
This registry record identifies a randomized comparison of three anesthetic techniques in children undergoing EGD and gives the primary outcome's broad definition and observation window. It also reports adverse-event counts by group. These details help describe what the study set out to compare and what safety entries were recorded.
The record does not report the primary respiratory-complication results, the statistical test actually used, or an effect estimate with uncertainty. It therefore does not allow readers to determine from the posted information whether the primary outcome differed among groups, how large any difference might have been, or how precisely it was estimated. The adverse-event counts cannot stand in for the missing primary outcome analysis because the registry does not establish that they represent the same endpoint or analysis.
General statistical context: a randomized design can strengthen causal interpretation when allocation, follow-up, outcome measurement, and analysis are appropriately conducted. The design label alone does not reveal whether these conditions were met. Information about allocation concealment, masking details, adherence, missing outcomes, and analysis populations is not reported in the registry record.
The results also should not be interpreted as a recommendation for a particular anesthetic technique. The posted information is insufficient to judge comparative effectiveness or safety across the three techniques. In particular, raw event counts do not show the precision of a comparison, and a count alone does not account for possible differences in ascertainment or classification.
What can be stated is limited: the registry describes the study question, design, timeframe, and reported adverse-event entries. A fuller interpretation of the trial's primary question requires the primary outcome results and analysis details, which are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial matters statistically because it frames an applied comparison in terms of a defined participant-level outcome and a short peri-operative observation period. The registry description links respiratory complications with a practical consideration, turnover of the gastrointestinal suite. That makes clear that the research question involves more than a single abstract statistical endpoint: the groups are compared in a clinical setting where both safety and procedure workflow were relevant to the stated rationale.
The randomized parallel design is a useful framework for comparing techniques, while the three-group structure raises questions about how an overall comparison and any group-specific contrasts should be interpreted. The registry description names chi-square or Fisher's exact testing, which are methods for categorical outcomes. The choice between them generally depends in part on the distribution of counts; the record does not say which method was used.
The available information also illustrates why outcome reporting needs to distinguish primary results from adverse-event summaries. Group-level serious and other adverse-event counts are reported, but primary respiratory-complication results are not. Without an effect estimate and its uncertainty for the primary endpoint, the central comparison cannot be evaluated statistically from the registry record.
More broadly, the record shows why design labels and enrollment information are not substitutes for results. Randomization describes assignment, and enrollment describes the study's scale, but neither establishes an outcome difference or its precision. Details of missing data, analysis populations, multiplicity, and masking would further support interpretation; these are not reported in the registry record. The statistical importance of the trial is therefore both in its stated comparative question and in the distinction between what its record documents and what remains unavailable.
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 principal limitation for interpretation is that the primary respiratory-complication results are not reported in the registry record. No group-level primary endpoint counts, effect estimate, confidence interval, p-value, or final test choice is available. The listed adverse-event entries cannot be assumed to be the primary endpoint.
The registry record gives an approximate primary-outcome timeframe but does not report detailed definitions for respiratory complications, event ascertainment, or rules for counting repeated events. The serious and other adverse-event categories are not defined in enough detail to determine whether they overlap. The denominators and group assignments associated with the listed serious terms are also not reported in the registry record.
The record identifies randomized allocation and single masking but does not describe allocation concealment or who was masked. It does not report the analysis population, outcome completeness, post-randomization exclusions, protocol deviations, or how missing data were handled. These omissions limit assessment of possible bias and the applicability of any comparison.
There is also a labeling ambiguity: intervention entries name “Zofran - no intubation” and “Propofol,” whereas the arm descriptions identify “Native Airway - no intubation” as the third arm. The registry record does not explain the relationship between these intervention and arm labels. The record lists peri-operative times as a secondary outcome but does not report the results or analysis details for that outcome. Finally, multiplicity procedures and the trial's own sample-size justification are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies — NCT02038894.
- Registry record last updated 2020-09-24; status last verified 2020-09.
- Results first posted 2020-09-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, randomized, parallel-group, single-masked trial sponsored by Children's Hospital Medical Center, Cincinnati. Enrollment is listed as 179. The study start is 2009-12 and primary completion is 2013-11.
The comparison concerns intubation with sevoflurane, intubation with propofol, and a native airway without intubation for children undergoing EGD. The primary outcome is the number of participants with respiratory complications from admission through recovery, approximately 3 hours. Peri-operative times are listed as a secondary outcome.
Serious and other adverse-event counts are reported by group, along with percentages for severe desaturation and apnea. The primary endpoint results, inferential comparison, and further analysis details are not reported in the registry record.