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 Manual Ventilation Efficacy With MVG Device (NCT05059366), a randomized na study. The primary outcome is Tidal Volume.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05059366 |
| Phase | NA |
| Condition | Ventilator Lung |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Miami |
| Results posted | Yes |
2. Clinical Question
Population
The study involved expert and novice participants performing manual ventilation on a manikin. Experts were described as anesthesiology residents and attendings with at least 2 or more years of clinical experience. Novices were described as current medical students or residents with no prior experience in hand mask ventilation techniques. The primary outcome description notes that 3 participants in the experts group were excluded because of unresolvable set-up obstacles.
Intervention
The intervention was the Manual Ventilation Grip Device, also called the MVG device. Participants used it to perform manual ventilation on a manikin.
Comparator
The comparator was the standard two-handed ventilation technique, identified in the registry as 2VE. The registry describes participants performing both techniques in different orders.
Primary question
The primary outcome was tidal volume, measured in milliliters using a ventilator machine on Day 1. The clinical question was whether tidal volume differed when participants used the MVG device rather than the standard 2VE technique. The registry record does not report the measured values or a statistical comparison, so the direction and magnitude of any difference cannot be determined.
3. Trial Design
This was a randomized, unmasked, crossover manikin study. The registry lists enrollment of 32 participants and describes expert and novice groups. Participants were assigned to an order of technique use: MVG followed by 2VE, or 2VE followed by MVG. Thus, the design included both device-first and standard-technique-first sequences. A crossover design can allow each participant to experience both conditions, but the registry record does not describe the analysis used to account for the paired measurements or the order in which techniques were performed.
The study was conducted at the University of Miami. The registry lists a start date of 2021-08-11, a primary completion date of 2021-08-20, and a status of completed. The official title describes an improvement in manual ventilation efficacy with a ventilation grip device in a manikin study. This is a simulation study rather than a study of patient outcomes; the study setting described in the record is ventilation of a manikin.
The primary outcome was tidal volume on Day 1, measured in milliliters using a ventilator machine. The registry also lists fatigue measured with the NASA-TLX questionnaire and fatigue measured with the SOFI questionnaire as secondary outcomes. Outcome values and statistical analyses are not reported in the registry record. The record lists no statistical analyses. It does not report details about sequence generation, the interval between techniques, participant flow by expertise group, or whether all enrolled participants contributed data to every outcome.
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 | Expert Participants Randomized to MVG Followed by 2VE | Expert Participants Randomized to 2VE Followed by MVG | Novice Participants Randomized to MVG Followed by 2VE | Novice Participants Randomized to 2VE Followed by MVG |
|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 |
| COMPLETED | 8 | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 3 participants in the experts group were excluded due to unresolvable set-up obstacles
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 | Experts Group | Novices Group | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 16 | 32 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 16 | 16 | 32 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 7 | 8 | 15 |
| Sex: Female, Male: Male | Participants | 9 | 8 | 17 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Tidal Volume, measured over Day 1.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | mL |
| Endpoint classification | Continuous Endpoint |
Tidal volume is the volume of air delivered during a ventilation breath. In this study it was measured in milliliters using a ventilator machine while participants ventilated a manikin, and the stated measurement timeframe was Day 1. The registry describes the outcome as a mean of a continuous measure, with standard error as the dispersion measure. It also notes that 3 participants in the experts group were excluded because of unresolvable set-up obstacles.
General: a continuous endpoint retains the magnitude of measured values, rather than reducing them to categories such as success or failure. A mean can describe the average observed volume in a group or condition. A standard error describes the uncertainty around an estimated mean; it is not the same as the spread of individual participant measurements. A comparison of means can help assess whether the average measured tidal volume differs between techniques, but its interpretation depends on the analysis and the uncertainty around the estimate.
Tidal volume is a measure of ventilation delivered in this simulated setting. It does not by itself establish how ventilation would perform in patients or describe other dimensions of ventilation. The registry record does not report mean tidal-volume values, standard errors, confidence intervals, or a test of the difference between techniques. The magnitude and precision of any observed contrast therefore cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies tidal volume as the primary outcome and describes it as a mean measured in milliliters on Day 1. It does not report the mean values for either technique, the estimated contrast, a confidence interval, or a p-value. Consequently, the posted record does not establish whether the observed tidal volume was higher, lower, or similar with the MVG device compared with the standard 2VE technique. It also does not show how precisely any difference was estimated.
The study used a crossover arrangement, with participants assigned to perform the techniques in different orders. In a crossover study, measurements from the same participant under different conditions are related. General: an analysis that accounts for this within-participant pairing can distinguish treatment-condition variation from differences between participants. Order can also matter if experience with one technique influences performance with the next. The registry record does not report whether the analysis accounted for pairing, sequence, or possible order effects.
The record describes expert and novice participants, but does not report outcome results separately for these groups or specify an analysis of group differences. The primary outcome description notes an exclusion of 3 participants in the experts group because of unresolved set-up obstacles. The record does not give the number analyzed for each technique or describe how the excluded participants were handled in outcome analyses. These gaps prevent a clear assessment of the analysis population.
The registry lists fatigue measured by NASA-TLX and SOFI questionnaires as secondary outcomes, but does not report their results. It lists no statistical analyses. Without outcome estimates, uncertainty measures, and analysis details, the results cannot be interpreted for statistical significance, precision, or consistency across outcomes. The absence of reported results in the registry record is not evidence that the techniques produced the same measurement; it means the comparison cannot be evaluated from this record.
9. Statistical Methods Explained
What does the crossover design mean?
The registry describes a randomized crossover study. Participants were assigned to perform the MVG device condition and the standard 2VE condition in different orders. In a crossover design, a participant can serve as their own comparator because measurements are taken under more than one condition. General: paired measurements often reduce the influence of stable differences between participants, since each participant's measurements can be compared with their own. This benefit depends on having usable measurements under both conditions and on applying an analysis that respects the paired structure.
Order is relevant because participants may become more familiar with the task, or the first condition may affect performance in the next condition. General: crossover analyses may need to consider sequence or period effects as well as the condition being compared. The registry record does not report the interval between conditions, whether there was a washout period, or whether sequence and order effects were assessed. No particular crossover analysis should therefore be inferred from the design description alone.
What does a mean and standard error describe?
The primary outcome is a continuous measure summarized as a mean, with standard error identified as the dispersion measure. General: the mean represents the average measured value in the analyzed observations. The standard error reflects uncertainty in an estimated mean and is affected by the amount of information contributing to that estimate. It does not describe the range or typical spread of individual measurements in the way a standard deviation does. The registry record does not give the tidal-volume means or standard errors, so neither the observed values nor their precision can be reviewed.
A confidence interval, if reported, would describe a range of values compatible with the data and the statistical model at a stated confidence level. General: a narrow interval indicates greater precision than a wide interval, while an interval spanning values on both sides of no difference may leave the direction of a contrast uncertain. No confidence interval or estimated contrast is reported in the registry record. No inference about statistical significance can be drawn from the endpoint description alone.
Why does the analysis population matter?
The primary outcome description says that 3 participants in the experts group were excluded because of unresolvable set-up obstacles. The registry does not explain which measurements were unavailable, whether participants were excluded from all outcomes or only a particular measurement, or how the analysis population was defined. General: exclusions can affect how well the analyzed participants represent those enrolled, and missing paired measurements can complicate a crossover comparison. A clear account of exclusions and the number analyzed for each condition is important for interpreting estimates.
The registry lists 32 participants enrolled. Enrollment is not necessarily the same as the number contributing data to a particular endpoint. The registry does not report participant counts for the tidal-volume analysis by expertise group, sequence, or condition. It also does not describe an approach to missing data. Accordingly, the completeness of the primary outcome data cannot be established from the record.
What does the absence of analysis details imply?
The registry lists no statistical analyses. It does not report a statistical model, a test, an adjustment strategy, or an estimate of the difference between techniques. General: a model for continuous outcomes can estimate a contrast and its uncertainty, while the design determines which sources of variation should be represented. For repeated observations, treating each measurement as independent when it is paired could misstate uncertainty. The appropriate analysis depends on the observations and the prespecified plan, neither of which is described in enough detail in the registry record.
The record lists NASA-TLX and SOFI fatigue measures as secondary outcomes, alongside the primary tidal-volume measure. It does not report how these outcomes were scored, how comparisons were planned, or whether any adjustment for multiple outcomes was intended. General: when several outcomes are tested, the chance of at least one apparently unusual result can increase if each is interpreted without regard to the set of tests. No multiplicity procedure or prespecified hierarchy is reported in the registry record.
There are no reported outcome estimates from which to recalculate a comparison. The record also does not report a trial-specific sample-size justification or power calculation. General: a planning calculation depends on assumptions about the effect to detect, outcome variability, allocation, and analysis. A planning illustration based on an observed effect would not be observed power and would not substitute for the trial's original design justification.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, tidal volume, and two secondary fatigue outcomes: NASA-TLX questionnaire fatigue and SOFI questionnaire fatigue. It does not report a prespecified testing hierarchy, multiplicity adjustment, or other strategy for interpreting results across these outcomes. General: when several statistical comparisons are made, interpreting each in isolation can increase the chance of a false-positive finding across the family of tests. A planned hierarchy or adjustment can help define how evidence across outcomes should be assessed. The registry record does not say whether such a plan existed.
The primary outcome description notes that 3 participants in the experts group were excluded because of unresolvable set-up obstacles. The record does not report whether any other outcome data were missing, the number of participants with measurements under each technique, or the handling of incomplete paired observations. It does not describe imputation, a complete-case approach, or a sensitivity analysis. These details are not reported in the registry record.
The registry lists enrollment of 32 participants, but the number enrolled is not necessarily the number analyzed for each outcome. It does not define an intention-to-treat or per-protocol analysis population, nor does it give endpoint-specific analysis counts. General: the analysis population and missing-data approach can affect both the estimate and the uncertainty, especially when the comparison depends on observations from both conditions in a crossover study.
The record lists no statistical analyses and provides no outcome estimates. Thus, multiplicity handling, missing-data methods, and the analysis population cannot be evaluated from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Manual Ventilation Grip Device (MVG) | 0 | 32 | 0.0% |
| Standard Technique (2VE) | 0 | 32 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Manual Ventilation Grip Device (MVG) | 0 of 32 |
| Standard Technique (2VE) | 0 of 32 |
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 |
|---|---|
| Manual Ventilation Grip Device (MVG) | 0 of 32 |
| Standard Technique (2VE) | 0 of 32 |
The registry lists two condition groups for adverse-event reporting: Manual Ventilation Grip Device (MVG) and Standard Technique (2VE). For each, it reports 32 participants at risk for serious adverse events and 0 serious events. It also reports 32 participants at risk for other adverse events and 0 other events, with 0 deaths in each group.
These are the adverse-event figures recorded in the registry. They should be read as event counts reported for the listed groups, not as a comparison demonstrating that either technique is safer. The record does not provide event descriptions, follow-up details, or an explanation of how adverse events were collected. Because the study is described as a manikin study, the safety figures do not provide information about patient adverse events.
The registry presents both groups with 32 participants at risk, but it does not explain how these group totals relate to the crossover sequence or to participants experiencing both techniques. The adverse-event counts therefore should not be treated as independent parallel-group observations without further details. The registry record reports no serious events, other events, or deaths in the listed groups; it does not establish that no unrecorded events occurred.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized, unmasked crossover study comparing the MVG device with the standard 2VE technique during ventilation of a manikin. It identifies tidal volume, measured in milliliters on Day 1, as the primary outcome. The record also lists fatigue measured with NASA-TLX and SOFI questionnaires. It does not report results for these outcomes or any statistical analyses.
As a result, the record cannot show whether tidal volume differed between techniques, how large any difference was, or how precisely it was estimated. It also cannot establish whether fatigue scores differed. No conclusion about the direction, magnitude, or statistical significance of an outcome comparison can be drawn from the information recorded.
The design concerns performance in a manikin setting, not patient outcomes. General: measurements in a simulated setting can address performance under the conditions of that simulation, but they do not automatically establish what would occur in clinical practice. The registry record does not report additional evidence about translation to patient care.
The adverse-event entries list zero serious adverse events, zero other adverse events, and zero deaths in each of the two named groups. These entries describe what the registry records; they do not constitute a comparative safety analysis and do not resolve the missing efficacy results.
The record is therefore informative about the study question, crossover arrangement, endpoint, and selected safety counts, but not about the outcome findings. The distinction matters: absence of posted estimates is not a finding of no difference. An interpretation of efficacy or of the precision of the comparison would require results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why a study design and an outcome definition are not enough to interpret a clinical comparison. The registry describes randomization, a crossover arrangement, two ventilation techniques, and a continuous primary measure. Those details explain what investigators set out to compare, but without outcome estimates they do not establish what the comparison found.
The crossover design also makes the relationship between measurements important. General: data from the same participant under two conditions are paired, and an analysis should reflect that dependence. The order of conditions can also be relevant. The registry describes different orders but does not report how paired measurements or possible order effects were handled. This is a useful reminder that the statistical structure follows the design, not simply the names of the intervention groups.
The record identifies an exclusion from the expert group and lists an enrollment total, yet does not report endpoint-specific analysis counts or the treatment of missing observations. Those details matter because the number enrolled may differ from the number contributing complete paired measurements. Transparent reporting of participant flow and analysis populations helps readers judge how directly results reflect the randomized participants.
Finally, the registry lists secondary fatigue outcomes and adverse-event counts but no outcome analyses. General: multiple endpoints require a clear plan for interpretation, while safety counts need context about ascertainment and the study setting. In this case, the record supports a careful description of the planned comparison and its reporting gaps, rather than a conclusion about effect. That distinction is central to responsible 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 principal limitation for interpreting the study from the registry record is that outcome values and statistical analyses are not reported. There are no tidal-volume means, standard errors, estimated contrasts, confidence intervals, or p-values. Results for the listed NASA-TLX and SOFI fatigue outcomes are also not reported. The size, direction, and precision of any comparison therefore cannot be assessed.
The record identifies a crossover design and different orders of technique use, but does not report the analysis model, how within-participant pairing was handled, or whether sequence and order effects were examined. It does not report the interval between conditions or other procedural details that would help assess possible carryover. These details are not reported in the registry record.
The primary outcome description notes that 3 participants in the experts group were excluded because of unresolvable set-up obstacles. The record does not explain the extent of missing measurements, give the numbers analyzed for each condition, or describe how incomplete data were handled. It also does not define the analysis population.
The study is described as a manikin study, so its setting is simulated ventilation rather than patient care. The record does not provide information that would establish how findings translate beyond that setting. Adverse-event entries report zero events and deaths in the listed groups, but event collection and follow-up details are not described. The registry record also does not report a trial-specific sample-size justification or a multiplicity plan.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Manual Ventilation Efficacy With MVG Device — NCT05059366.
- Registry record last updated 2022-07-18; status last verified 2022-07.
- Results first posted 2022-07-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05059366 is a completed randomized, unmasked crossover manikin study sponsored by the University of Miami. The registry lists enrollment of 32 participants and dates the study start to 2021-08-11 and primary completion to 2021-08-20. Participants were assigned to perform the MVG device and standard 2VE technique in different orders; the record describes expert and novice participants.
The primary outcome was mean tidal volume in milliliters measured on Day 1 with a ventilator machine. The record notes that 3 participants in the experts group were excluded because of unresolvable set-up obstacles. Secondary outcomes were fatigue measured using NASA-TLX and SOFI questionnaires.
The registry lists zero serious adverse events, zero other adverse events, and zero deaths in both named groups. It does not report outcome values, statistical analyses, or the methods used to address missing data or multiplicity. As a result, the outcome comparison and its precision cannot be assessed from the registry record.