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 Nebulized Hypertonic Saline for Mechanically Ventilated Children (NCT01945944), a randomized phase 1, phase 2 study. The primary outcome is Duration of Mechanical Ventilation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01945944 |
| Phase | Phase 1, Phase 2 |
| Condition | Respiratory Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 18 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University Hospitals Cleveland Medical Center |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns children with respiratory failure who require mechanical ventilation. The registry rationale is that thick secretions can obstruct the breathing tube and windpipe, potentially worsening lung function and prolonging ventilation. Hypertonic saline was proposed as a way to thin secretions when inhaled by children receiving ventilatory support.
The primary outcome was duration of mechanical ventilation, measured in hours. The registry lists a median of 129.5 hours for the placebo arm and 208.1 hours for the hypertonic saline arm. Each arm included 9 participants. These are descriptive results: a comparative statistical analysis, such as a test or confidence interval for the treatment contrast, is not reported in the registry record. The posted medians alone therefore do not establish whether any observed difference is compatible with chance or whether the intervention caused a change.
Population
Children with respiratory failure who need mechanical ventilation. The registry rationale focuses on secretion-related obstruction in the breathing tube and windpipe.
Intervention
Nebulized hypertonic saline (3%), 3mL every 6hrs for up to 7 days.
Comparator
Nebulized placebo (0.9% saline), 3mL every 6 hrs for up to 7 days.
Primary question
How does the duration of mechanical ventilation, recorded in hours, compare between the randomized arms?
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel-group phase 1/phase 2 trial. Enrollment was 18, with 9 participants listed in each arm. The trial status is completed. Its recorded start is 2013-10, and its primary completion is 2014-04. University Hospitals Cleveland Medical Center is listed as the sponsor.
Participants were assigned to nebulized hypertonic saline (3%) or nebulized placebo (0.9% saline). Both arm descriptions specify 3mL on a six-hour schedule for up to 7 days. The registry calls the study randomized and quadruple-masked, but does not identify which groups of people were masked or describe the randomization or allocation-concealment procedures. Those details are not reported in the registry record.
The primary outcome was duration of mechanical ventilation, measured in hours and summarized by median and interquartile range. The registry gives the timeframe as typically 4 days - 2 weeks. Eight secondary outcomes are listed: atelectasis, wheezing, ICU length of stay, hospital length of stay, change in serum sodium from baseline, dynamic compliance, oxygenation, and dead space. The record lists 9 outcome measures in total, but does not provide posted analysis results for the secondary outcomes.
The registry record does not report the eligibility criteria, participant characteristics, sites, or the details of follow-up and outcome assessment. It also does not report a protocol or a statistical analysis plan. The design description establishes that the trial was randomized and masked; it does not, by itself, explain how those procedures were implemented or how the results were analyzed.
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 | Placebo | Hypertonic Saline |
|---|---|---|
| STARTED | 9 | 9 |
| COMPLETED | 8 | 6 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Placebo | Hypertonic Saline |
|---|---|---|
| Adverse Event | 0 | 2 |
| Physician Decision | 1 | 0 |
| Withdrawal by Subject | 0 | 1 |
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 | Placebo | Hypertonic Saline | Total |
|---|---|---|---|---|
| Participants analysed | 9 | 9 | 18 | |
| Age, Continuous | weeks | 26 (3.1 to 174.2) | 12.7 (5.6 to 32.6) | 17.9 (5.1 to 44.0) |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 6 | 7 | 13 |
| Race/Ethnicity, Customized: African-American | participants | 4 | 5 | 9 |
| Race/Ethnicity, Customized: Caucasian | participants | 5 | 3 | 8 |
| Race/Ethnicity, Customized: Other | participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 9 | 9 | 18 |
| PEEP (positive end-expiratory pressure) | cm-H20 | 5 (5 to 6) | 7 (6.5 to 8) | 6 (5 to 7) |
6. Primary Endpoint
The registry lists the primary outcome as Duration of Mechanical Ventilation, measured over typically 4 days - 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | hours |
| Endpoint classification | not reduced to a single comparison |
Duration of mechanical ventilation measures the time a participant remains on ventilatory support. The registry records this outcome in hours and specifies a median with an interquartile range. Its stated timeframe is typically 4 days - 2 weeks. The registry rationale connects the endpoint to the concern that thick secretions may obstruct the breathing tube or windpipe and prolong the need for ventilation.
In general, a median describes the middle of an ordered set of observations. An interquartile range describes the central half of those observations, from the first to the third quartile. It conveys how spread out the observed values are, but it is not a confidence interval for the median or for a comparison between arms. That distinction matters when interpreting the posted values: the registry provides a summary of each arm's observed duration, but does not report an interval estimate or a statistical test for the difference between arms.
The posted median is 129.5 hours in the placebo arm, with an interquartile range from 74.4 to 146.1 hours. In the hypertonic saline arm, the median is 208.1 hours, with an interquartile range from 136.3 to 319.8 hours. These summaries describe the participants in the respective arms. The registry does not report the individual observations, a comparative estimate, or details of how ventilation duration was defined and recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is summarized separately for each arm. Among 9 participants assigned to placebo, the median duration of mechanical ventilation was 129.5 hours, with an interquartile range of 74.4 to 146.1 hours. Among 9 assigned to hypertonic saline, the median was 208.1 hours, with an interquartile range of 136.3 to 319.8 hours. Descriptively, the posted median is lower in the placebo arm. This is a statement about the observed summaries, not a conclusion about a treatment effect.
No p-value, confidence interval for an arm comparison, adjusted estimate, or other comparative analysis of the primary outcome is reported in the registry record. Without such an analysis, the precision of the between-arm contrast cannot be assessed from these summaries alone. The interquartile ranges describe the spread of observed durations within each arm; they do not quantify uncertainty about the treatment contrast. A statistical test or confidence interval should not be inferred from the arm medians and ranges.
The trial enrolled 18 participants, with 9 in each arm. With this number of participants, the individual observations can have substantial influence on the summaries, particularly for an outcome that can vary across participants. The registry does not post individual-level data or enough distributional detail to examine that influence. The record also does not describe missing outcome data or how such data were handled, so the completeness of the primary endpoint cannot be assessed from the posted results.
Randomization is intended, in general, to support a fair comparison by balancing participant characteristics across groups on average. In a small trial, randomization does not ensure that the groups are alike on every characteristic. Participant characteristics by arm are not reported in the registry record, so the balance achieved in this trial cannot be evaluated. Quadruple masking is listed, but the registry does not specify who was masked or whether masking was maintained.
The result should therefore be read as a small trial's arm-specific descriptive summaries, rather than as evidence that one assigned regimen changed ventilation duration. The registry's brief summary states a hypothesis that inhaled hypertonic saline could shorten ventilation, but a stated hypothesis is not an analysis result. The primary comparison's statistical uncertainty and the basis for any causal interpretation are not reported in the registry record.
9. Statistical Methods Explained
The posted primary outcome is reported as a median and interquartile range for each randomized arm. This choice describes the center and spread of observed ventilation durations without requiring the mean to represent a typical participant. In general, a median is the central ordered observation or midpoint, depending on the number of observations. The interquartile range spans the middle half of the observations. It is a descriptive range, not a confidence interval. The registry does not explain why this summary was selected or report the individual durations.
What can the arm summaries tell us?
They show the reported central value and spread within each arm. For placebo, the median is 129.5 hours and the interquartile range is 74.4 to 146.1 hours. For hypertonic saline, the median is 208.1 hours and the interquartile range is 136.3 to 319.8 hours. These summaries do not themselves estimate the uncertainty of a between-arm contrast. In general, a confidence interval for a contrast gives a range of values compatible with the data and the method's assumptions. No such interval is reported for the primary comparison.
The registry's outcome type is not reduced to one comparison, and it lists no analyses. A primary outcome may be summarized in the registry without a complete inferential analysis. The record does not state whether the investigators used a test, a model, an adjustment, or an alternative method to compare ventilation duration. None should be assumed. The reported arm values are not a substitute for those analysis details.
Why does the outcome distribution matter?
In general, clinical duration outcomes may have uneven distributions: some participants can have much longer durations than others. A median can be useful for describing the typical observation when a few longer values could pull an arithmetic mean. The interquartile range gives a robust description of spread. However, choosing a descriptive summary does not determine the appropriate inferential analysis. The registry does not report the shape of the individual data or the analysis method used for the primary endpoint.
Duration of mechanical ventilation can also be affected by how the endpoint is defined and by what happens to participants before ventilation ends. In general, a time-to-event analysis may account for differing follow-up or participants whose event is not observed during follow-up. The registry does not report whether the primary outcome was analyzed as a time-to-event endpoint, how the event was defined, or how any such circumstances were handled. No particular analysis can be inferred from the endpoint name alone.
How should the planning illustrations be read?
The planning assumptions described for the trial's sample-size illustrations use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They frame the effect to detect as a stated fraction of the observed effect. For time-to-event planning, the stated convention is to give a total number of events using the Schoenfeld method; other planning results are expressed as participants per arm. These are planning illustrations, not observed trial outcomes, and they are not observed power.
In general, a sample-size calculation asks how much information a future study might need under specified assumptions. It does not show that a completed study had a particular probability of detecting an effect after its results are known. The registry does not report a trial-specific sample-size justification, and no numerical planning results are stated in the record details described for this trial. The illustrations therefore cannot establish the design rationale or adequacy of the enrolled sample.
What do the missing analysis details mean?
The statistical analysis plan, handling of missing observations, analysis populations, and any interim analyses are not reported in the registry record. In general, an analysis population specifies which randomized participants contribute to a particular result, while a missing-data method explains how unavailable outcome measurements are treated. These decisions can affect interpretation, but they cannot be reconstructed from the arm-level summaries. The record also does not report adjusted or unadjusted comparative estimates for the primary endpoint.
Eight secondary outcomes are listed, but their results and analysis methods are not reported in the registry record. When several outcomes are examined, multiplicity can matter: in general, making many statistical comparisons can increase the chance of finding an apparently notable result by chance. The record does not report a multiplicity strategy or identify any secondary-outcome analysis. It is therefore not possible to assess how those issues were addressed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, duration of mechanical ventilation, and eight secondary outcomes: atelectasis, wheezing, ICU length of stay, hospital length of stay, change in serum sodium from baseline, dynamic compliance, oxygenation, and dead space. The record lists 9 outcome measures in total. It does not report analysis results for the secondary outcomes, and it does not report how the primary and secondary outcomes were prioritized in the statistical analysis.
In general, evaluating many outcomes can raise a multiplicity issue: the chance of at least one apparently unusual result can increase when multiple comparisons are made. Researchers may specify an adjustment, a testing hierarchy, or another strategy in advance. Whether such a strategy was planned or used is not reported in the registry record. No claim about multiplicity adjustment can be made from the outcome list alone.
The registry does not report the statistical analysis plan, missing-data methods, analysis populations, or interim analyses. It therefore does not establish whether all randomized participants were included in the primary analysis, whether any outcome values were missing, or how missing values were handled. The number of participants in each posted arm is 9, but the record does not explain whether that set is identical to the analysis population for the primary endpoint.
In general, missing outcome data can affect both the precision and interpretation of a comparison, depending on how much is missing and why. Without reporting on completeness and handling, readers cannot assess this issue. The record also does not report protocol deviations or exclusions from analysis. These omissions limit the ability to evaluate the analysis process, independently of the descriptive outcome values that are posted.
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 |
|---|---|---|---|
| Placebo | 0 | 9 | 0.0% |
| Hypertonic Saline | 2 | 9 | 22.2% |
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 |
|---|---|
| Placebo | 0 of 9 |
| Hypertonic Saline | 0 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Hypertonic Saline |
|---|---|---|---|
| Desaturation (oxygen) | Respiratory, thoracic and mediastinal disorders | 0 of 9 | 2 of 9 |
Serious events with the highest arm-level rate: desaturation (oxygen) (22.2%).
The registry lists 9 participants at risk for serious adverse events in each arm. It records 0 affected in the placebo arm and 2 affected in the hypertonic saline arm. The most frequently listed serious adverse event term is “Desaturation (oxygen),” at 22.2%. The registry does not specify in the registry entries how that term is distributed between arms, so it should not be assigned to a particular group on the basis of these figures alone.
The record lists 0 other adverse events in each arm. Death counts are not reported in the registry record. The serious-event figures are counts for this small enrolled group; they do not by themselves establish a difference in safety between assigned treatments. In general, event counts can be imprecise when few participants are observed, and a comparison requires attention to uncertainty as well as the counts.
The registry does not provide further event descriptions, timing, severity grading, relatedness assessments, or an analysis comparing the arms. The term and percentage should therefore be read as the posted safety summary, not as a complete account of the circumstances or a causal attribution. The record's figures do not support medical advice or a conclusion about the safety of either regimen beyond what was observed and reported.
12. What the Result Does, and Does Not, Mean
The posted primary results describe ventilation duration among 18 participants randomized between placebo and hypertonic saline, with 9 participants in each arm. The median was 129.5 hours in the placebo arm and 208.1 hours in the hypertonic saline arm. The interquartile ranges were 74.4 to 146.1 hours and 136.3 to 319.8 hours, respectively. These are observed arm-level summaries, not a reported estimate of the treatment contrast.
The registry record does not report a p-value or confidence interval for the primary comparison. It is therefore not possible to assess the statistical uncertainty around a comparative effect from the posted summaries. The record also does not report the analysis plan, missing-data handling, participant characteristics, or analysis populations. Those gaps limit what can be concluded about the robustness and interpretation of the results.
The study's stated hypothesis was that inhaled hypertonic saline could shorten mechanical ventilation. The posted median is numerically lower in the placebo arm, but the descriptive summaries alone cannot determine whether the observed pattern reflects a real difference, chance variation, or other features of the trial. They also do not establish whether the assigned treatment caused a change in ventilation duration.
The posted safety counts show 0 serious adverse events among 9 participants in the placebo arm and 2 among 9 in the hypertonic saline arm; the most frequently listed serious event term is desaturation (oxygen), at 22.2%. The registry does not report deaths, and it does not provide enough detail to interpret that term by arm. These counts are a limited description, not a comprehensive safety comparison.
In short, this record supports a description of the trial design and the posted summaries. It does not establish the size or precision of a comparative effect, nor does it provide enough information for a definitive causal or safety conclusion.
13. Why This Trial Matters Statistically
This trial is statistically notable as a small randomized comparison with a clinically interpretable duration outcome. Ventilation duration is reported in hours, and the registry gives a median and interquartile range for each arm. Those summaries make the observed distribution easier to describe than a single value would, but they do not replace an estimate of the between-arm contrast with uncertainty.
The trial also illustrates why design labels and analysis results are distinct. The registry identifies randomization, quadruple masking, and a parallel model. Those design features matter to how a trial is conducted, but the record does not describe their implementation or report a comparative statistical analysis. Readers cannot infer statistical significance or precision solely from randomization and arm-level medians.
With 9 participants per arm, each observation can matter to the summary, and the posted interquartile ranges communicate some of the observed variation. General statistical reasoning cautions against treating a difference between two medians as conclusive evidence about an underlying treatment effect, especially when a comparative estimate and its uncertainty are unavailable. The record leaves those inferential questions unresolved.
The trial also lists several secondary outcomes, but their analysis results and any strategy for handling multiple comparisons are not reported. This illustrates the importance of distinguishing a list of measured outcomes from a prespecified analysis plan and a set of interpreted results. Likewise, safety counts provide useful descriptive information but are not, alone, a reliable comparative safety assessment.
The record's value lies in making the trial question, design, primary outcome, and available descriptive results identifiable. Its limitations also show why transparent reporting of analysis methods, missing-data handling, participant flow, and uncertainty estimates is important for interpreting small clinical trials.
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 trial enrolled 18 participants, with 9 in each arm. This small enrollment limits the amount of information available for characterizing the outcome distributions and comparing the groups. The registry does not report a confidence interval or statistical test for the primary comparison, so the precision of any treatment contrast is unknown from the posted results.
Participant characteristics and eligibility criteria are not reported in the registry record. It is therefore not possible to assess the enrolled population in detail or examine how characteristics were distributed between arms. Although the study is listed as randomized and quadruple-masked, the registry does not describe the randomization procedures, allocation concealment, which roles were masked, or whether masking was maintained.
The record gives arm-level summaries, but does not report individual outcome values, details of outcome assessment, or how duration of mechanical ventilation was operationally defined. It also does not report the analysis populations, missing-data handling, protocol deviations, or a statistical analysis plan. The completeness of the primary outcome and the analysis choices therefore cannot be evaluated.
Eight secondary outcomes are listed, but their results are not reported in the registry record. A multiplicity strategy is also not reported. Safety information is limited to the posted adverse-event counts and the most frequently listed serious event term; event timing, severity details, relatedness, and deaths are not reported in the registry record.
The registry does not report a trial-specific sample-size justification. The described planning approach is an illustration based on the observed effect, not evidence of the study's original design rationale. Together, these reporting gaps constrain interpretation of both the primary result and the safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nebulized Hypertonic Saline for Mechanically Ventilated Children — NCT01945944.
- Registry record last updated 2016-06-28; status last verified 2016-05.
- Results first posted 2016-06-28.
- 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 record concerns NCT01945944, “Nebulized Hypertonic Saline for Mechanically Ventilated Children,” sponsored by University Hospitals Cleveland Medical Center. It is listed as a completed, randomized, quadruple-masked, parallel-group phase 1/phase 2 trial, with enrollment of 18. The recorded start is 2013-10 and primary completion is 2014-04.
The arms received nebulized hypertonic saline (3%) or placebo (0.9% saline), each described as 3mL on a six-hour schedule for up to 7 days. The primary outcome was duration of mechanical ventilation in hours, summarized by median and interquartile range. The posted median was 129.5 hours for placebo and 208.1 hours for hypertonic saline, with 9 participants in each arm.
The registry lists eight secondary outcomes. Their analysis results, a comparative analysis of the primary outcome, and details of the statistical analysis plan are not reported in the registry record. The safety summary lists 0 serious adverse events in placebo and 2 in hypertonic saline; death counts are not reported.