Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE (NCT02284178), a randomized na study. The primary outcome is Microaspiration as Measured by Tracheal Amylase.

2. Clinical Question

3. Trial Design

NO-ASPIRATE (NCT02284178) is recorded as a completed, randomized, triple-masked, parallel-group trial sponsored by the University of Central Florida. Enrollment was 513. The registry lists respiratory failure as the condition. The recorded start was 2014-08, and primary completion was 2017-08. The registry does not report the original sample-size justification or explain how the enrollment count relates to the numbers included in the posted outcome summaries.

Participants were assigned to enhanced oral suction or usual-care oral suction. The enhanced arm is described as deep oropharyngeal suction with a catheter; the usual-care arm is described as oropharyngeal suction with a suction swab. The general study summary frames the intervention as a standardized, enhanced suction protocol and the comparator as standard suction. Further operational details, including the precise suction schedule and adherence, are not reported in the registry record.

The primary outcome was tracheal amylase, measured in U/L. Specimens were to be obtained every 12 hours for up to 14 days, or until participants no longer met inclusion criteria; examples include extubation and tracheostomy. The posted arm summaries include 206 participants in the enhanced group and 204 in the usual-care group. Those outcome counts are not the same as the enrollment count, but the registry record does not explain the difference or describe the analysis population.

The registry lists Ventilator-Associated Condition (VAC) Rate and Time to VAC as secondary outcomes. VAC was assessed for two days beyond the last intervention; the record gives a mean assessment duration of 5.4 days. Definitions of the VAC event, the time origin for Time to VAC, and the handling of participants who did not experience VAC are not reported in the registry record.

Although triple masking is recorded, the masked parties and procedures are not described. The record also does not report details of sequence generation, allocation concealment, site count, baseline characteristics, or intervention fidelity. These omissions limit how fully the conduct and comparability of the trial groups can be assessed from the registry record alone.

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

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Microaspiration as Measured by Tracheal Amylase, measured over Every 12 hours up to 14 days.

The primary endpoint is tracheal amylase, reported as a mean concentration in U/L. The study summary identifies leakage of secretions around the breathing tube as microaspiration and describes microaspiration as a contributor to complications associated with mechanical ventilation. Tracheal amylase is the recorded measure used to assess this process. The registry specifies specimen collection every 12 hours for up to 14 days, or until a participant no longer met inclusion criteria, such as after extubation or tracheostomy.

A continuous laboratory measure can capture differences in measured levels rather than only whether a participant crossed a prespecified event threshold. The registry reports the outcome as a mean with standard deviation for each arm. The record does not state what concentration would represent a clinically important difference, whether a particular measurement time or summary across time was primary, or how repeated specimens were combined for the primary estimand. Those details matter when interpreting what a group mean represents.

As general context, a biomarker can help quantify a biological process, but a difference in a biomarker is not automatically equivalent to a difference in a clinical outcome. The registry separately lists VAC outcomes, but it does not report that tracheal amylase is a validated substitute for those outcomes. Interpretation should therefore stay close to the stated measure: the posted primary results compare measured tracheal amylase between the randomized groups.

7. Results Posted in the Registry

• Enhanced Oral Suction: mean 13,086 versus 15,298 on control; difference -2,212 (95% CI -8,312 to 3,888), standardized effect d = -0.07; z-test p = 0.477.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Ventilator-Associated Condition (VAC) Rate

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Enhanced Oral Suction: 15.0% (31/206) versus 15.7% (32/204) on control; risk difference -0.6 percentage points (95% CI -7.6 to 6.3), risk ratio 0.96 (0.61–1.51); unadjusted two-proportion z-test p = 0.858.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Enhanced Oral Suction and the control. The interval gives the range of effects that remain compatible with the data.

Time to VAC

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Enhanced Oral Suction: mean 4.94 versus 5.72 on control; difference -0.78 (95% CI -1.25 to -0.31), standardized effect d = -0.32; z-test p = 0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Enhanced Oral Suction than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Across the two listed secondary outcomes, the posted pattern is mixed in the sense that the VAC event counts are similar between groups, while the Time to VAC mean is lower in the enhanced group. The registry reports a chi-squared result for VAC Rate but gives no reported analysis for Time to VAC. The recalculated Time to VAC comparison is unadjusted and should be treated as exploratory context rather than as a substitute for a prespecified sponsor analysis.

These outcomes relate to the primary question because the study summary proposes that enhanced suction could reduce microaspiration and other ventilator-associated conditions. Tracheal amylase is the primary measure of microaspiration; VAC outcomes represent separate clinical outcomes. The registry does not report a formal analysis connecting changes in tracheal amylase to VAC, nor does it establish that a change in one should predict a change in the other. Agreement or difference across these measures cannot by itself establish a mechanism.

Unadjusted secondary results carry less weight when several outcomes or analyses are examined because the chance of at least one apparently unusual result can increase as more comparisons are made. As general statistical context, prespecifying a testing hierarchy or adjusting for multiplicity can help control that concern. The registry does not report a multiplicity adjustment, a hierarchy of hypotheses, or whether these secondary comparisons were confirmatory or exploratory. Their interpretation should therefore remain cautious and should account for the absence of those details.

The registry lists eight outcome measures and seven analyses, but it does not explain the relation between those counts or provide a complete analysis plan. The two named secondary outcomes are the ones posted in the record. Without full definitions, analysis populations, missing-data rules, and prespecification details, the secondary results are best viewed as additional descriptive evidence rather than independent confirmation of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Ventilator-Associated Condition (VAC) Rate
• Time to VAC

9. Statistical Interpretation

10. Statistical Methods Explained

Comparing continuous outcomes. The primary outcome is continuous: tracheal amylase in U/L. The registry reports the mean and standard deviation in each arm. A mean difference expresses the difference between group means in the outcome's original units. The simple unadjusted recalculation compares the enhanced group's posted mean with the usual-care group's posted mean. Its estimate is -2212.0 U/L. This calculation does not adjust for baseline variables or other features of the trial and should not be mistaken for the registry's own model-based analysis.

What a standard deviation describes. A standard deviation describes the spread of individual measurements around a group mean; it is not a confidence interval and does not, by itself, express the precision of the mean. The primary outcome standard deviations are large relative to the difference between the posted means. This reflects considerable variation in the measurements, although the registry does not explain whether the reported spread is calculated across participant-level summaries or across another unit of observation. For Time to VAC, the registry also reports means and standard deviations, with the outcome measured in days.

Repeated measurements and GEE. The primary specimens were scheduled every 12 hours for up to 14 days or until a participant no longer met inclusion criteria. Repeated observations from the same participant are generally correlated: measurements from one person may be more alike than measurements from different people. As general statistical context, generalized estimating equations (GEE) are a family of methods often used to estimate average relationships while accounting for within-participant correlation. The registry reports a GEE analysis for the primary comparison, but does not report the model formula, working correlation structure, covariates, handling of missing observations, or the precise outcome summary being estimated. Those details cannot be inferred from the method label alone.

Unadjusted recalculation and sponsor-reported analysis. The recalculated primary estimate and confidence interval use posted group summary statistics and are unadjusted. The registry's own primary result is a GEE analysis with p = 0.432, but no estimate or confidence interval is posted for that analysis. These are distinct analyses: the simple recalculation provides an interpretable comparison of the arm means, while the registry result reflects the analysis method it records. The recalculated p-value is not a replacement for the registry's analysis.

Binary outcome methods. VAC Rate is posted as a count of participants, so it is a binary outcome: each participant is classified according to whether VAC occurred. The registry reports a chi-squared analysis. As general context, a chi-squared test evaluates whether observed counts across categories are compatible with no association between group and outcome, under its assumptions. The recalculated risk difference expresses the difference in the observed proportions; a confidence interval for a risk difference describes uncertainty in that absolute contrast. The registry's posted analysis reports p = 0.858. It does not give a confidence interval for the sponsor-reported test or explain whether any adjustments were applied.

Time to VAC. The registry labels Time to VAC as a mean measured in days and supplies group means and standard deviations. The simple recalculation is a mean difference, with a confidence interval and unadjusted p-value. The record does not report a sponsor analysis for this outcome. Despite the outcome's name, the posted summaries are means and standard deviations; the registry does not describe a time-to-event model, censoring rules, or how participants without VAC were handled. A more specific method should not be inferred from the label alone.

Confidence intervals and p-values. A confidence interval gives a range of estimates compatible with the data under the assumptions of the analysis. It conveys both the direction and the uncertainty of an estimate and is usually more informative than a p-value alone. A p-value measures how incompatible the observed data are with a specified null model, given the analysis assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. In this trial, the recalculated primary interval includes zero; the registry-reported GEE result supplies a p-value but no interval or effect estimate.

Over-dispersion and variability. As general statistical context, over-dispersion arises when count data vary more than a model assumes. That can make standard errors too small if the excess variation is ignored. The registry reports a chi-squared comparison for the binary VAC outcome, not a count regression model, and does not report an over-dispersion assessment. The concept is relevant to count models in general but should not be presented as a finding about this trial.

What is not specified. The registry does not report the original statistical analysis plan, the original sample-size assumptions, any interim analyses, the primary estimand in detail, adjustment covariates, missing-data methods, or the populations used for each analysis. The method labels and summary statistics permit limited interpretation, but they do not disclose all decisions required to reproduce the analyses. Further design and analysis details are therefore not reported in the registry record.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -2212.0 U/L, with a 95% confidence interval from -8312.0 to 3888.0 U/L. The interval crosses zero, so values consistent with the posted summaries include a lower mean in the enhanced group and a higher mean in that group. Its width indicates substantial uncertainty about the size and direction of the simple group contrast. The unadjusted p-value is 0.477. The registry's own GEE analysis reports p = 0.432 but does not report an estimate or confidence interval, so its precision cannot be judged from the posted result alone.

As general explanation, a confidence interval is not a range containing a fixed proportion of individual participant measurements. It is a range of plausible values for the quantity estimated under the assumptions of the method. A wide interval can reflect limited information, variability, or both; in this trial the primary arm summaries show substantial spread, but the registry does not provide enough analysis detail to attribute the interval's width to particular causes.

The secondary outcomes have different precision and analysis reporting. The recalculated VAC risk-difference interval extends from -0.076 to 0.063. The Time to VAC mean-difference interval extends from -1.247 to -0.313 days, but that comparison is a recalculation rather than a registry-reported analysis. The registry's VAC analysis reports a p-value without an interval. Differences in outcome type and analysis method mean these intervals should not be treated as directly interchangeable.

Precision is distinct from clinical importance. The registry record does not specify a clinically important threshold for tracheal amylase or the secondary outcomes. It therefore does not establish how large a difference would matter to patients or clinical care. The confidence intervals describe statistical uncertainty in the estimates; they do not supply that missing threshold.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on observed effects, not the trial's original design justification. For the continuous primary outcome and the continuous Time to VAC outcome, the figures are participants per arm. For the binary VAC outcome, they are also participants per arm. The record's note about total events applies to time-to-event tables; these posted outcome illustrations do not give total events. The original design assumptions are not reported in the registry record.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each row uses a stated fraction of the observed effect: the full observed effect, 75% of the observed effect, or 50% of the observed effect. These are hypothetical target effects for planning, not new observed results. The illustrations do not establish what effect the investigators originally expected when designing the trial.

The 80% power column gives the estimated number of participants per arm for a design that would have an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true one. The 90% power column gives the corresponding planning number for a 90% chance. Power is a property of a proposed design under assumptions, not a probability that a particular conclusion is correct. These figures are not observed power.

Smaller effects require more participants to detect, all else being equal. That pattern appears across the illustrations: rows targeting a smaller fraction of the observed effect require larger planned group sizes. The estimates are sensitive to their assumptions and should be read as planning guides rather than fixed requirements. They do not account for unreported design choices, such as missing outcomes, repeated-measures structure, or any adjustment strategy, because those details are not part of the stated planning assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2212.000; pooled standard deviation σ = 31454.294.
2. n = 2 × (1.96 + 0.842)² × 31454.294² / -2212.000² = 3,174.1, rounded up to 3,175 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2212                      # observed difference in means
sigma <- 31454.2938583113                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2284178)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 3,175 (80% power), 4,250 (90% power)
 75% of observed effect: n per arm = 5,643 (80% power), 7,555 (90% power)
 50% of observed effect: n per arm = 12,697 (80% power), 16,998 (90% power)
power.t.test: 3175.1 
Simulated power at n = 3,175 per arm: 0.794 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's own primary analysis is described as GEE and reports p = 0.432. It does not post an effect estimate, confidence interval, model specification, or covariate details for that analysis. The recalculation from the arm means gives a mean difference of -2212.0 U/L, a 95% confidence interval of -8312.0 to 3888.0 U/L, and an unadjusted p-value of 0.477.

The recalculation is a simple unadjusted comparison of posted summary statistics; it is not a reconstruction of the GEE model. Because the primary measurements were scheduled repeatedly, the GEE result may address the data differently from a comparison of two arm means, but the exact distinction cannot be established without the model details. The p-values are therefore not interchangeable, and their modest numerical difference does not by itself identify why the analyses differ.

The registry record does not flag a discrepancy between the posted summaries and reported analysis. The sponsor-reported result remains the trial's own listed analysis, while the recalculation offers a transparent, limited comparison based on the posted means and standard deviations. Neither should be read without regard to its method and the uncertainty in the estimate.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures and seven analyses, as well as the two named secondary outcomes. It does not report which hypotheses were designated primary or secondary in the original analysis plan beyond the posted primary endpoint and listed secondary outcomes. The hierarchy of testing, any adjustment for multiple comparisons, and the intended role of each analysis are not reported in the registry record.

Multiplicity matters because each additional outcome or analysis creates another opportunity for an apparently notable result to arise by chance. As general statistical context, a prespecified outcome hierarchy or a method that adjusts inference across comparisons can address this issue, but no such approach is reported. The unadjusted secondary results should not be interpreted as though they were protected from multiplicity unless the analysis plan establishes that.

Missing-data procedures are not reported. The primary specimens were scheduled every 12 hours for up to 14 days or until participants no longer met inclusion criteria, but the record does not say how unavailable samples were handled, how many scheduled samples were missing, or whether a participant-level summary or another repeated-measures summary was analyzed. Extubation and tracheostomy are given as examples of reasons a participant might no longer meet inclusion criteria; the analysis consequences of those events are not described.

The registry reports a GEE analysis for the primary outcome, but does not state the analysis population, model specification, assumptions about missing observations, or any sensitivity analyses. It also does not report whether analyses followed randomized assignment or used another population definition. Details on interim analyses, stopping rules, and deviations from an original statistical analysis plan are not reported in the registry record. These gaps limit assessment of robustness and reproducibility; they do not establish that any particular analysis choice was made.

16. 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 records zero serious adverse events among 206 participants at risk in the enhanced oral suction group and zero among 204 participants at risk in the usual-care group. It also records zero other adverse events in each group. Deaths are listed separately: 41 in the enhanced group and 49 in the usual-care group.

These are counts as posted, not adjusted comparisons. The registry does not provide event definitions, timing, causes of death, attribution to the intervention, or a statistical analysis of these safety figures. In particular, the death counts should not be interpreted as evidence that suction assignment caused or prevented deaths. The zero adverse-event counts do not establish that no harms occurred outside the registry's recorded categories or reporting window. The posted figures are limited descriptive information and do not by themselves establish comparative safety.

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

The registry documents a randomized comparison of enhanced oral suction with usual-care oral suction and posts primary and secondary outcome summaries. For the primary endpoint, the posted arm means differ, but the simple unadjusted estimate is imprecise: its confidence interval includes zero and allows differences in either direction. The registry's GEE analysis reports p = 0.432, without an effect estimate or confidence interval. These results describe uncertainty in the available summaries; they do not prove that the groups are identical or establish a particular clinical effect.

The secondary outcomes provide additional observations, but their interpretation is constrained by the limited reporting. The VAC analysis has a reported chi-squared p-value, whereas no sponsor-reported analysis is listed for Time to VAC. The registry does not report a multiplicity strategy or a complete statistical analysis plan. As a result, the secondary findings should not be treated as definitive confirmation of the primary result or as independent proof of a benefit or harm.

The primary endpoint is a measure of tracheal amylase used to assess microaspiration. A statistical difference in this measure would not automatically show a change in clinical outcomes, and the record does not state a threshold for clinical importance or establish a validated relationship between the biomarker and VAC. The posted summaries also do not clarify how repeated measurements were combined or how incomplete follow-up was addressed.

The results cannot determine how the findings apply to groups or settings not described in the registry record. Detailed eligibility criteria, baseline characteristics, site information, adherence, and analysis populations are not reported. These limits call for a careful reading of the recorded comparisons rather than a broad claim about effectiveness, lack of effectiveness, or safety.

18. Why This Trial Matters Statistically

This trial illustrates a common statistical challenge in clinical research: a biologically motivated primary measure is collected repeatedly, while clinical outcomes are also tracked. Tracheal amylase is intended to measure microaspiration, and VAC outcomes address a separate ventilator-associated condition. Keeping those outcome types distinct helps prevent a biomarker result from being treated as though it were automatically a clinical outcome result.

The posted primary summaries also demonstrate why an estimate and its uncertainty matter together. A mean difference alone gives a direction and scale, but its confidence interval indicates how much uncertainty remains. Here the recalculated interval spans zero and extends in both directions. A p-value alone would not communicate that range or whether an effect might be clinically important; the registry's GEE result is reported without an estimate or interval.

The record identifies GEE for the primary analysis, yet leaves the model details and handling of repeated observations unreported. This is a useful reminder that a method label does not fully specify an analysis. For repeated measurements, the unit of analysis, correlation structure, missing-data assumptions, and target estimand can all shape interpretation. Those details are necessary for replication and for understanding why a model-based result may differ from a simple summary-statistic comparison.

Finally, the secondary outcomes and adverse-event counts show the value of separating descriptive reporting from confirmatory inference. Multiple outcomes can broaden the clinical picture, but their evidential role depends on prespecification, analysis plans, and multiplicity handling. When those details are absent, readers can still describe the posted pattern while keeping conclusions proportional to the uncertainty and reporting limitations.

19. 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.

Several limitations are specific to the available record. Although enrollment was 513, the posted primary summaries include 206 participants in the enhanced arm and 204 in the usual-care arm. The registry does not explain how these outcome counts relate to enrollment, what analysis population they represent, or why the counts differ. No attrition flow or participant disposition is reported.

The primary specimens were scheduled repeatedly, but the registry does not explain whether the posted means summarize individual participants, all specimens, or another unit. It reports a GEE p-value without the model estimate, confidence interval, model structure, or missing-data approach. That prevents a full appraisal or reproduction of the primary analysis. The recalculated unadjusted comparison cannot resolve those omissions.

The registry gives limited information on trial conduct. Triple masking is recorded, but the masked parties and procedures are not described. Sequence generation, allocation concealment, baseline characteristics, site count, protocol adherence, and detailed eligibility criteria are not reported. The record also does not give the original design assumptions, a statistical analysis plan, interim-analysis details, or stopping rules.

Outcome interpretation is also constrained. The registry does not define a clinically important difference in tracheal amylase, provide a formal relation between the biomarker and VAC, or fully specify the VAC and Time to VAC analysis methods. Multiplicity handling and missing-data procedures are not reported. The adverse-event summary lacks event definitions, timing, and attribution information. These are limits of the registry record and should not be taken as evidence that the underlying trial did not collect or address the information.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE — NCT02284178.
• Registry record last updated 2019-08-15; status last verified 2019-07.
• Results first posted 2019-08-15.
• 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.

23. Record Summary

NO-ASPIRATE (NCT02284178) is recorded as a completed randomized, triple-masked, parallel-group trial sponsored by the University of Central Florida, with enrollment of 513. It compared enhanced oral suction, described as deep oropharyngeal suction with a catheter, with usual-care oral suction, described as oropharyngeal suction with a suction swab.

The primary outcome was tracheal amylase in U/L, assessed every 12 hours for up to 14 days or until participants no longer met inclusion criteria. The registry reports a GEE analysis with p = 0.432. A simple recalculation from the posted arm means gives a mean difference of -2212.0 U/L and a 95% confidence interval of -8312.0 to 3888.0 U/L.

The listed secondary outcomes were VAC Rate and Time to VAC. The record posts outcome summaries and limited analyses, but does not report a complete statistical plan, missing-data procedures, or multiplicity handling. Interpretation is therefore bounded by the posted estimates and the details available in the registry record.