THRIVE Use in Pediatric Populations- Multi Site: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for THRIVE Use in Pediatric Populations- Multi Site (NCT04322994), a randomized na study. The primary outcome is Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index.

2. Clinical Question

3. Trial Design

The trial is identified as a randomized, prospective, multisite study with a parallel design. Its title is “THRIVE Use in Pediatric Populations- Multi Site.” The registry record lists Stanford University as the sponsor, an enrollment of 175, and a completed status. The start date is 2020-10-21 and the primary completion date is 2024-01-19. Phase is listed as NA.

The intervention was high-flow nasal cannula during the scheduled procedure, applied before the procedure began and removed after it ended. Control participants underwent the procedure and recovery with usual care. The record also mentions a brief post-recovery questionnaire for applicable patients or their parents, guardians, or representatives. The information available does not describe the questionnaire results.

Masking is listed as none. Thus, the registry identifies the study as unmasked; it does not describe who knew each participant’s assignment or whether outcome assessment was blinded. The record does not report details such as the randomization sequence, allocation concealment, site-level procedures, or the precise intervention flow settings. Those design details are not reported in the registry record.

The listed primary outcome concerns participants with a 4% decrease from baseline in oxygen desaturation index during the procedure. Secondary outcomes include time-normalized area under the curve of desaturations <90%, participants with surgical interruptions due to desaturation, and minimum oxygen saturation. Although the record lists an enrollment of 175, it does not give the primary-outcome group counts or a single treatment-effect estimate. The meaning of the design is therefore clear at a broad level, but the registry information does not support an estimate of the primary comparison.

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: Participants who completed the protocol.

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: Participants who completed the protocol.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index, measured over Duration of surgery or procedure, which is generally less than 2 hours.

The primary endpoint is the number of participants with a 4% decrease from baseline in oxygen desaturation index. The record defines oxygen desaturation index as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds. Measurements were recorded every 2 seconds while the procedure was being performed. The stated timeframe is the duration of surgery or the procedure, generally less than 2 hours.

This endpoint represents whether a participant experienced the specified desaturation pattern, rather than the total duration or depth of every desaturation event. Counting participants with an event can make a result straightforward to interpret as an event frequency, while the threshold and duration rule distinguish qualifying events from shorter or smaller fluctuations. Those features are part of the registry’s definition; the record does not explain why this particular threshold was selected.

For a binary endpoint, the group counts and the number of participants assessed in each group are needed to estimate event proportions and compare groups. The registry record does not report the primary outcome counts or a single comparison. The primary outcome population is described as participants who completed the protocol, but the number in that population is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is recorded?

The primary measure is a participant-level event count: whether each participant had the defined oxygen desaturation index event during the procedure. This is a binary outcome, because each participant is classified as having or not having the event for the relevant analysis. For such outcomes, a basic summary is the number of participants with an event alongside the number assessed in each group. A group proportion expresses how common the event was among the assessed participants. These general descriptions do not imply that a particular statistical method was used in this trial.

A comparison might report a difference in event proportions, a ratio of proportions, or another effect measure. Each describes the contrast in a different scale. An effect estimate should be read with its confidence interval, which expresses the uncertainty around the estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval; an interval that includes no difference is compatible with a range of effects that includes no group contrast. The registry record does not report a primary effect estimate, confidence interval, or p-value.

How does randomization relate to the comparison?

In general, random assignment aims to make treatment groups comparable at the start of a trial, on average, including with respect to factors that are measured and factors that are not measured. A parallel design assigns participants to a group that remains their assigned group for the comparison, rather than having each participant receive both conditions in sequence. These are general properties of the design labels, not evidence about how successfully the trial implemented its allocation procedures. The sequence-generation and allocation-concealment methods are not reported in the registry record.

Masking is listed as none. In general, lack of masking can matter when awareness of assignment could affect care, measurement, or decisions to record an event. The primary endpoint is based on oxygen-saturation measurements and a rule for defining an event, but the registry does not describe whether the readings were reviewed automatically or by assessors, or whether measurement staff knew assignment. Such implementation details are not reported in the registry record.

What does the endpoint definition contribute?

The event rule uses a 4% decrease relative to a 120 second rolling mean, lasting greater than 10 seconds, with measurements recorded every 2 seconds during the procedure. In general, an explicit threshold and duration make an endpoint more reproducible by specifying which observed changes count as events. A rolling mean provides a moving reference for the measurement, rather than relying only on a single fixed value. The registry does not describe the rationale for these choices, the handling of missing measurement intervals, or the method used to determine whether the event occurred for each participant.

When repeated measurements are reduced to a participant-level yes-or-no outcome, the comparison concerns the proportion of participants with at least one qualifying event, according to the study’s analysis rules. That is distinct from analyzing every oxygen-saturation reading as a separate observation. Treating repeated readings from the same participant as independent would generally ignore their correlation; methods for repeated measurements need to account for that dependence when the readings themselves are analyzed. The posted primary outcome is described as a participant count, and no repeated-measure analysis method is reported.

What can planning assumptions tell readers?

The registry’s planning description refers to an illustration based on the observed effect, two-sided significance level 0.05, equal allocation between groups, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such planning illustrations can show how a hypothetical detectable effect changes under chosen assumptions. They are not the trial’s observed results, and they are not observed power. The record does not report the trial’s own sample-size justification, and numerical planning estimates are not reported in the registry information available for this analysis.

In general, planning calculations depend on the outcome type, assumed event frequency or effect, chosen error rate, allocation, and analytic method. If the planning effect is taken from an observed estimate, its uncertainty also matters: an unstable observed effect can make a planning illustration misleadingly optimistic or pessimistic. The record does not report enough information to assess such assumptions or to reconstruct a sample-size calculation.

What analysis choices remain unknown?

The registry record does not report the statistical test or model used for the primary comparison, whether the analysis followed assigned treatment groups, how missing outcomes were handled, or whether adjustment was made for site or baseline characteristics. For binary outcomes, common general approaches include comparing proportions or modeling the probability of an event. The appropriate approach depends on the prespecified analysis, data structure, and assumptions. Naming these options is general statistical context, not a statement that the trial used any one of them.

Over-dispersion is a general concern when observed variation exceeds what a model’s assumed distribution allows. For repeated or clustered data, such as measurements grouped within participants or participants within sites, ignoring dependence can make uncertainty estimates too small. Whether over-dispersion or clustering was relevant to the final analysis cannot be determined from the registry record. No model diagnostics or adjustment procedures are reported.

Any recalculation based on summary statistics would be an unadjusted calculation and would not replace a sponsor’s own analysis if the two differed. The available record does not include the outcome summaries needed for a recalculation. The sponsor’s own analysis takes precedence if a discrepancy is reported, but no discrepancy is identified in the registry information.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures and 9 analyses. The primary outcome is described by a threshold-based event definition, but the registry record notes that the primary outcome has several categories or time points and is not reduced to one comparison. No single primary-outcome contrast is therefore available for interpretation in the posted results.

Multiplicity arises when several outcomes, time points, groups, or statistical tests are examined. In general, the more comparisons considered, the greater the chance that at least one result appears notable by chance if each is assessed separately. Prespecified testing hierarchies or adjustment methods can address aspects of this issue, but whether either was used in this trial is not reported in the registry record. The presence of multiple listed measures alone does not establish that a particular correction was required or applied.

Missing-data handling is also not reported in the registry record. The stated primary-outcome population is participants who completed the protocol. The record does not say how many participants completed it, whether all randomized participants were included in the analysis, how incomplete oxygen-saturation recordings were treated, or whether any imputation or sensitivity analysis was conducted. Without those details, the potential influence of missing outcomes on the comparison cannot be assessed.

The record does not describe an analysis population beyond the primary endpoint’s completed-protocol description, nor does it report whether the comparison was by randomized assignment or another approach. Interim analyses, stopping rules, and the complete statistical analysis plan are not reported in the registry record. These omissions limit assessment of how outcome selection, missing data, and multiplicity were addressed.

11. 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.

The adverse-event summary lists the control group with 88 participants at risk and zero serious adverse events, zero other adverse events, and zero deaths. The high-flow nasal cannula group has 87 participants at risk, with zero serious adverse events, zero other adverse events, and zero deaths. These figures describe what the registry reports for the listed groups.

Zero recorded events in a group does not establish that the true event risk is zero. Rare events can remain compatible with a zero count, and the estimate’s precision depends on the number assessed and the completeness of safety reporting. The registry summary does not give event descriptions, observation windows, severity criteria, or details of adverse-event collection. No serious adverse event terms are listed.

These counts should not be read as proof that the groups have the same safety profile. A comparative safety estimate, with its uncertainty, is not reported in the registry record. The counts also do not describe the primary oxygen-desaturation outcome, which is a separate endpoint.

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

The trial record documents a randomized, unmasked, parallel comparison of usual care with high-flow nasal cannula during pediatric procedures under anesthesia. It defines an oxygen-desaturation event using a 4% decrease from a 120 second rolling mean lasting greater than 10 seconds, and identifies participants who completed the protocol as the primary outcome population. This information helps clarify what the study intended to examine.

It does not establish whether high-flow nasal cannula changed the frequency of the primary endpoint. The primary outcome is not reduced to one comparison, and the group event counts, effect estimate, confidence interval, and p-value are not reported in the registry record. The secondary outcome names do not supply their results. Consequently, the record does not permit a conclusion about the magnitude, direction, or precision of an outcome difference.

The serious adverse event summary reports zero events in both groups, but those counts alone do not establish absence of risk or equivalence between groups. The registry does not describe collection methods or the full context needed to assess safety reporting. Likewise, the completed status and enrollment figure do not establish that all enrolled participants contributed data to each outcome analysis.

In general, a trial’s result should be interpreted using its prespecified question, analyzed population, effect estimate, uncertainty, and limitations. The registry information available for this analysis supplies only part of that picture. It supports describing the study’s design and outcome definitions, not declaring a treatment benefit, lack of benefit, or safety advantage.

13. Why This Trial Matters Statistically

This trial addresses a statistical challenge common to procedural research: an outcome can be defined from measurements taken repeatedly during a short period, but the clinical question may concern how many participants experience a qualifying event. Here, the registry’s definition uses a rolling reference, a specified decrease, and a minimum duration. Each choice shapes which measurements count and therefore what the participant-level event means.

The design is randomized and parallel, so the intended comparison is between assigned groups rather than a before-and-after comparison within the same participants. Interpreting such a comparison requires the outcome counts and a measure of uncertainty, not just the study’s enrollment or completion status. The primary comparison is not reported as one result in the registry information available for this analysis. This makes transparent reporting as important as the endpoint definition itself.

The listed secondary outcomes also illustrate that desaturation can be described in different ways: a time-normalized area under the curve, interruptions attributed to desaturation, and minimum oxygen saturation. These measures address different features of the event experience. They should not be treated as interchangeable, and the registry record does not provide their numerical findings.

Finally, the safety summary demonstrates why zero counts require careful interpretation. Counts can be reported clearly, but their meaning depends on the population observed, how events were sought, and the uncertainty around rare events. A completed randomized trial can still leave key questions unresolved when comparative estimates, analysis details, and missing-data information are not reported. That distinction is central to sound statistical interpretation.

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 registry record gives limited information for evaluating the trial’s conduct and analysis. The primary outcome is not reduced to a single comparison, and group event counts, effect estimates, confidence intervals, and p-values are not reported. As a result, the observed primary-outcome difference and its precision cannot be described.

The primary analysis population is described as participants who completed the protocol, but the number of participants who completed it is not reported in the registry record. The record also does not report the handling of missing readings or outcomes, whether every randomized participant was analyzed, or how protocol deviations were treated. Enrollment is not a substitute for those analysis details.

The intervention description is incomplete in the registry information available for this analysis. It states that a high-flow nasal cannula delivered oxygen, air, or a mixture, but the remaining description is not available. Specific flow settings, duration details beyond placement during the procedure, and intervention adherence are not reported in the registry record. Usual-care respiratory practices are not further specified either.

Other details important to appraisal are also not reported in the registry record: randomization procedures, allocation concealment, site-specific methods, outcome-assessment procedures, the statistical analysis plan, multiplicity handling, and interim analyses. The record lists no masking, but does not explain whether outcome assessors knew assignment. These limitations constrain assessment of potential bias and analysis choices. The listed safety counts are useful descriptive information but lack accompanying event definitions and collection details.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: THRIVE Use in Pediatric Populations- Multi Site — NCT04322994.
• Registry record last updated 2025-03-27; status last verified 2025-03.
• Results first posted 2025-03-27.
• 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 record identifies NCT04322994 as a completed, randomized, prospective, multisite, parallel study sponsored by Stanford University. Enrollment is listed as 175. The start date is 2020-10-21 and the primary completion date is 2024-01-19; phase is listed as NA. Masking is listed as none.

The study compared usual care with high-flow nasal cannula during pediatric procedures under anesthesia. Its primary outcome was the number of participants with a 4% decrease from baseline in oxygen desaturation index, using the stated rolling-mean and duration definition. Secondary outcomes included desaturation area under the curve, surgical interruptions due to desaturation, and minimum oxygen saturation.

The registry information available for this analysis does not report a single primary comparison or its numerical results. It lists zero serious adverse events, zero other adverse events, and zero deaths in each group. Details of the analysis plan, missing-data handling, and completed-protocol population are not reported in the registry record.