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 Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning (NCT01069185), a randomized na study. The primary outcome is Primary Composite End Point.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01069185 |
| Phase | NA |
| Condition | Hypoxemia, Arrhythmias, Cardiac Arrest |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 92 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Hospital Pablo Tobón Uribe |
| Results posted | Yes |
2. Clinical Question
Population
Children receiving endotracheal suctioning during intubation in the Pediatric Intensive Care Unit at Hospital Pablo Tobón Uribe. The registry lists 92 participants enrolled and reports arm sizes of 47 for necessity suctioning and 45 for routine suctioning.
Intervention
Necessity endotracheal suctioning, in which suctioning depends on clinical manifestations. The registry describes assessment of the primary outcome during the intubation period.
Comparator
Routine endotracheal suctioning, described as suctioning every two hours. The study used a parallel-group randomized design and reported no masking.
Primary question
Does the frequency of morbidity events associated with suctioning differ between a necessity-based protocol and a routine protocol? The registry defines the primary composite outcome as events including hypoxaemia, unplanned extubation, cardiac arrhythmias, and cardiac arrest. It describes changes identified on the patient monitor by a nurse and/or confirmed directly by a pediatrician.
The question concerns morbidity events recorded during or after suctioning, with assessment during the intubation period. For the routine protocol, suctioning was scheduled every two hours; under the necessity protocol, timing depended on the patient’s need. This difference in exposure schedule matters when interpreting a count of events: the registry does not explain whether repeated events in the same patient were counted separately, or how the time at risk was handled.
The registry also lists mechanical ventilation length in days as a secondary outcome. It does not provide a posted result for that outcome in the record. The clinical question is therefore best read as a comparison of the recorded primary morbidity-event counts, rather than as a complete assessment of every possible outcome of the two suctioning approaches.
3. Trial Design
The registry describes a randomized, parallel-group trial with no masking. Participants were assigned to necessity endotracheal suctioning or routine endotracheal suctioning. The necessity protocol based suctioning on clinical manifestations; the routine protocol specified suctioning every two hours. The study was conducted in the Pediatric Intensive Care Unit at Hospital Pablo Tobón Uribe, whose name also appears as the sponsor.
The registry reports enrollment of 92. The arm records list 47 participants for necessity suctioning and 45 for routine suctioning. The study status is completed. The start is recorded as 2010-02 and primary completion as 2010-08. The registry does not report masking, and the design field identifies the study as parallel rather than crossover.
Random assignment is intended to make treatment groups comparable on average, including for characteristics that may not be measured. It does not guarantee that the groups are identical, especially in a trial of this scale, and it does not by itself resolve issues in outcome measurement or analysis. With no masking, participants and clinical staff could know which suctioning protocol was in use. The registry does not report whether outcome assessment was otherwise blinded or describe steps taken to reduce assessment bias.
The primary outcome is described as a composite of morbidity events assessed during or after suctioning and during the intubation period. The registry lists mechanical ventilation length as a secondary outcome and identifies two outcome measures, but it does not provide a posted statistical analysis for these measures. A protocol, detailed allocation procedure, and the basis for the enrollment target are not reported in the registry record. No further design details should be inferred from the brief description.
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 | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|
| STARTED | 47 | 45 |
| COMPLETED | 47 | 45 |
| NOT COMPLETED | 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 | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|---|
| Participants analysed | 47 | 45 | 92 | |
| Age, Continuous | months | 34 (7 to 104) | 56 (14 to 108) | 40.5 (8.3 to 107.1) |
| Sex: Female, Male: Female | Participants | 21 | 23 | 44 |
| Sex: Female, Male: Male | Participants | 26 | 22 | 48 |
| Weight | Kgs | 15 (7 to 31) | 15 (10 to 30) | 15 (7.6 to 30) |
| PRISM | units on a scale | 23 (14 to 28) | 23 (17 to 27) | 23 (15 to 26.5) |
6. Primary Endpoint
The registry lists the primary outcome as Primary Composite End Point, measured over Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period ..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | event |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Primary Composite End Point” and is recorded as a number of events. The registry describes “all causes of morbidity” as hypoxaemia, unplanned extubation, cardiac arrhythmias, and cardiac arrest. It says these events were identified through a change in the patient’s monitor by an ancillary nurse and/or confirmed directly by a pediatrician. The endpoint could be assessed during or after suctioning, with assessment in each patient during the intubation period.
A composite endpoint groups multiple clinical events into a shared outcome. In general, this can capture a broader range of morbidity than any single component, but the combined count does not show which component contributes most unless component-specific results are reported. The registry does not report component-level counts, so the posted arm totals cannot establish how the constituent events were distributed.
The outcome is a count, not a reported rate or a participant-level risk estimate. The registry does not clarify whether an individual could contribute repeated events, how events were adjudicated when identification and confirmation differed, or how duration of intubation was accounted for. Those details affect the meaning of a count, particularly when the protocol determines how often suctioning occurs. Ventilator-associated pneumonia appears elsewhere in the record, but it is not included in the registry’s stated list of primary composite components.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome records 35 events in the necessity endotracheal suctioning arm and 48 events in the routine endotracheal suctioning arm. The registry lists arm sizes of 47 and 45, respectively. These are descriptive counts. They should not be read as participant risks, rates, or a treatment effect: the record does not say whether events could recur within a patient, provide person-time, or report a statistical comparison that accounts for the outcome’s count structure.
The record lists no analyses for the outcome and states that values are missing or not estimable for a two-arm comparison of this count endpoint. It therefore does not report an inferential estimate, confidence interval, or p-value for the difference between protocols. The descriptive count pattern alone cannot establish whether the observed difference is compatible with chance variation, whether the protocols differ statistically, or how precisely any underlying effect has been estimated. The sponsor’s own analysis does not take precedence over another analysis in this case because no sponsor analysis is posted in the registry record.
Interpretation is further limited by the endpoint definition and exposure schedule. The primary outcome combines several types of morbidity, but component-specific counts are not reported. The protocol also governs the timing of suctioning: one arm follows clinical manifestations and the other has suctioning every two hours. The registry does not explain how the number or timing of suctioning opportunities relates to the event count, or whether follow-up duration differed between participants.
The posted data support a description of the recorded counts and the study’s design. They do not support a causal or clinical conclusion about whether one protocol is preferable. Randomization is relevant to causal interpretation, but it cannot replace a clearly reported analysis, uncertainty estimate, and transparent handling of repeated events and time at risk. The registry does not report these elements.
Planning illustrations based on an observed effect are not observed power and do not repair the missing inferential analysis. For this count endpoint, the record explicitly notes that values were not available or estimable for a two-arm comparison. The counts should therefore remain descriptive, with no extrapolation to a precise effect or a definitive comparison.
9. Statistical Methods Explained
The posted outcome is a count of morbidity events. Statistical methods for counts differ from methods for continuous measurements or binary outcomes because counts can include repeated events and may have a distribution that is not well represented by a normal model. The registry does not report which model, if any, was used for the primary outcome. It lists no analyses and says values are missing or not estimable for a two-arm comparison.
Why is a count endpoint different?
A count records how many events occurred, while a binary outcome records whether an event occurred at least once for each participant. If participants can experience recurrent events, a count can reflect both the number of affected participants and recurrence among those participants. The registry does not clarify whether repeated events contributed repeatedly to the primary outcome. Without that information, the values cannot be interpreted as numbers of participants with morbidity.
Counts may also depend on the amount of time participants are observed or on how often an event can occur. In this trial, the endpoint was assessed during the intubation period, and suctioning schedules differed by protocol. The record does not state how duration of intubation or exposure to suctioning was incorporated into analysis. A rate model can account for differing time at risk when suitable time data are available, but such an analysis cannot be reconstructed from the posted information.
What does over-dispersion mean?
In general, over-dispersion occurs when count outcomes vary more than a simple model expects. It can arise when event counts differ substantially between participants or when events cluster within people. If over-dispersion is ignored, standard errors may be too small and confidence intervals may be too narrow. Analysts may use models that allow extra variability or use methods that account for clustering, depending on the data structure. The registry does not report a dispersion estimate, an event-level dataset, or a method for handling repeated events, so it is not possible to determine whether over-dispersion was assessed.
What would an estimate and confidence interval add?
A treatment-effect estimate would express the comparison on a specified scale, such as a difference in event counts or a ratio of rates. The scale and model need to fit the study question and data. A confidence interval communicates the uncertainty around an estimate: a narrower interval indicates greater precision under the method’s assumptions, while a wider interval indicates less precision. The registry record does not report an estimate or confidence interval for the primary endpoint. No such quantity can be derived reliably from the two arm totals alone because participant-level recurrence and observation time are not described.
A p-value, if reported, would address how compatible the data are with a specified null hypothesis under the chosen model. It would not measure the size or clinical importance of a difference, nor would it resolve whether the model’s assumptions are appropriate. No p-value or inferential test for the primary comparison is reported. The record’s statement that the values are missing or not estimable for a two-arm comparison is important: it means the descriptive counts should not be treated as if a valid model-based result were available.
How should planning illustrations be read?
The registry describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are hypothetical design calculations, not evidence of the trial’s observed power. They depend on assumptions about the effect to detect and the analysis model. For a count endpoint that cannot be reduced to a single comparison in the posted record, a sample-size illustration may not be estimable. The registry’s note about missing or non-estimable values should be kept distinct from any observed outcome count.
In general, a power calculation is a planning tool tied to an assumed effect, variability, model, and significance threshold. It does not establish the probability that a result is true, and observed power is not a substitute for an uncertainty interval. No protocol-based sample-size justification, target effect, interim analysis plan, or detailed statistical analysis plan is reported in the registry record. Those omissions prevent a fuller assessment of whether the enrollment target and chosen methods were appropriate for the endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry names a primary composite endpoint and lists mechanical ventilation length in days as a secondary outcome. It reports two outcome measures, but no analysis is posted for either measure. The registry does not report a multiplicity plan describing how inference across outcomes or endpoint components would be handled. Because the composite includes several events, component-specific testing could also raise multiplicity concerns; component-level results and any adjustment strategy are not reported.
Missing-data procedures and analysis populations are not reported in the registry record. The record does not state whether the primary analysis was intention-to-treat, per-protocol, or based on another population. It also does not explain how missing outcome observations, incomplete follow-up, or changes in intubation duration were handled. No participant flow or reasons for missingness are described in the registry record for this record.
These omissions matter because conclusions can depend on which participants are included and how missing outcomes are treated. In general, an intention-to-treat analysis retains participants in their randomized groups, while other analysis populations may answer different questions and can be more vulnerable to bias. Missingness can also distort a comparison if it is related to treatment assignment or outcome status. These are general methodological considerations, not claims about what happened in this trial.
The registry’s lack of a posted analysis should not be mistaken for evidence that no analysis was performed outside the record. It means the registry record does not permit readers to assess the selected analysis population, missing-data assumptions, multiplicity control, or the robustness of the reported counts.
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 |
|---|---|---|---|
| Necessity Endotracheal Suctioning | 0 | 47 | 0.0% |
| Routine Endotracheal Suctioning | 1 | 45 | 2.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Necessity Endotracheal Suctioning | 9 of 47 |
| Routine Endotracheal Suctioning | 12 of 45 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Necessity Endotracheal Suctioning | 0 of 45 |
| Routine Endotracheal Suctioning | 0 of 47 |
Most frequent serious adverse event terms
| Event term | Organ system | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|---|
| VAP | Respiratory, thoracic and mediastinal disorders | 0 of 47 | 1 of 45 |
Serious events with the highest arm-level rate: vap (2.2%).
The adverse-event entries list 0 serious events among 47 at risk for the necessity endotracheal suctioning group and 1 serious event among 45 at risk for the routine endotracheal suctioning group. They also list deaths of 9 and 12, respectively, under those group entries. These figures are reported as registry counts; they are not adjusted comparisons, and the record does not provide a statistical analysis of them.
The entries for other adverse events use different at-risk counts: 45 for the necessity group and 47 for the routine group, with 0 other events in each entry. The registry does not explain why those at-risk values differ from the serious-event entries or how the categories were defined. The serious-event term list includes VAP at 2.2%, but the record does not attribute that term to an arm or provide enough context to connect it to the primary composite endpoint.
Safety counts should be interpreted in light of the reporting definitions, follow-up, and time at risk. Those details are not reported in the registry record. The death counts should not be assumed to be caused by suctioning, and the serious-event counts should not be read as a treatment effect. The entries describe what the registry reports, not a causal safety comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized parallel-group trial compared suctioning based on clinical manifestations with suctioning every two hours in a pediatric intensive care unit. It reports morbidity-event counts of 35 in the necessity group and 48 in the routine group, alongside arm sizes of 47 and 45. These figures describe the posted results but do not provide an inferential comparison or a measure of uncertainty.
The outcome combines hypoxaemia, unplanned extubation, cardiac arrhythmias, and cardiac arrest. Without component-specific results, the counts do not show which events contributed to the composite. Without clarification on repeat events and time at risk, they also cannot be interpreted as the number or proportion of participants affected. The registry does not report a participant-level risk, event rate, effect estimate, confidence interval, or p-value for the primary comparison.
Random allocation can support a causal comparison when the analysis respects the design and outcome data are adequately reported. It does not make descriptive counts self-interpreting. In this record, the missing analysis and details of event counting limit what can be concluded from the numerical pattern. The absence of a posted inferential result does not establish that the protocols are equivalent, nor does it establish that they differ.
The secondary outcome of mechanical ventilation length in days is named but no result is reported in the registry record. Safety entries include serious events and deaths, but they are descriptive and lack the context needed to infer whether suctioning caused them. The record therefore supports a cautious account of study design and recorded counts, not a clinical recommendation or a definitive judgment about comparative benefit or harm.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint type and analysis reporting matter. A count of morbidity events is not automatically a count of participants affected. If an individual can contribute repeated events, the total combines event occurrence and recurrence. If observation time varies, raw counts may also reflect different time at risk. The registry’s description does not resolve these issues.
The study also compares protocols that determine suctioning timing differently: one relies on clinical manifestations, while the other schedules suctioning every two hours. The primary outcome is assessed during or after suctioning and during the intubation period. This makes the definition of an event, the observation window, and the handling of exposure opportunities especially relevant to interpreting a count comparison.
Randomization is an important design feature, but a clear analysis remains necessary to translate outcomes into an estimate with uncertainty. The registry reports the arm counts but no analysis, confidence interval, or p-value, and it notes that the count outcome cannot be reduced to an estimable two-arm comparison in the record. This distinction helps readers avoid treating a numerical difference in counts as proof of a reliable effect.
The record also highlights the value of reporting component outcomes, missing-data handling, analysis populations, and safety definitions. Those details would let readers judge what the composite captures and how complete the comparison is. Their absence limits statistical interpretation without erasing the descriptive information that is available.
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 primary outcome is reported as a count, but the registry does not explain whether repeat events in a participant were counted more than once. It also does not report participant-level outcomes, time at risk, or whether observation duration varied. These omissions prevent interpretation of the totals as risks or rates and prevent reconstruction of a suitable event-count analysis.
The composite combines hypoxaemia, unplanned extubation, cardiac arrhythmias, and cardiac arrest, yet component-specific counts are not reported. The registry does not provide operational definitions, adjudication procedures, or details on resolving differences between monitor identification and clinician confirmation. The assessment window is described as during or after suctioning and during intubation, but the exact follow-up and event-attribution rules are not reported.
The record lists no analyses and gives no inferential estimate, confidence interval, or p-value for the primary comparison. It does not report the statistical model, handling of over-dispersion or repeated events, analysis population, missing-data method, multiplicity plan, or protocol-based sample-size justification. The secondary outcome is named without a posted result. Masking is listed as none, and the record does not state whether outcome assessors were otherwise blinded.
Safety reporting also has limits: the at-risk values differ between serious and other adverse-event entries, and the registry does not explain the categories or follow-up context. The VAP term is not attributed to an arm. These limitations mean the record supports descriptive reporting, but not a complete assessment of effect size, precision, endpoint components, or causality.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning — NCT01069185.
- Registry record last updated 2017-09-11; status last verified 2017-09.
- Results first posted 2017-09-11.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed randomized, unmasked, parallel-group trial sponsored by Hospital Pablo Tobón Uribe. It enrolled 92 participants in a pediatric intensive care unit, with 47 listed in the necessity endotracheal suctioning arm and 45 in the routine arm. The necessity protocol depended on clinical manifestations; the routine protocol specified suctioning every two hours.
The primary composite endpoint counted morbidity events, including hypoxaemia, unplanned extubation, cardiac arrhythmias, and cardiac arrest, assessed during the intubation period. The registry reports 35 events for necessity suctioning and 48 for routine suctioning. It lists mechanical ventilation length in days as a secondary outcome but posts no analysis. The record does not provide an inferential comparison, uncertainty estimate, or details needed to interpret the counts as participant risks or rates. Serious-event and death entries are descriptive, with reporting context and analysis not reported in the registry record.