A Study to Evaluate SimPull for Lateral Patient Transfer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate SimPull for Lateral Patient Transfer (NCT05856123), a non-randomized na study. The primary outcome is Time to Complete Lateral Transfer.

2. Clinical Question

The practical question is whether the recorded transfer time differed between the group using SimPull and the group using standard-of-care methods. Time is a direct measure of how long the transfer took, but it does not by itself capture other aspects of the process, such as staff experience or safety. The registry also lists clinician satisfaction and the number of clinician survey responses indicating that a clinician was very likely to experience injury during transfers as secondary outcomes.

The design can describe the transfers observed in each group, but the non-randomized allocation makes a like-for-like causal comparison difficult. Differences between groups could reflect factors other than the transfer method. The registry does not report details about how those factors were measured or addressed in analysis. Because numerical endpoint findings are not reported, the posted record cannot establish the direction or size of any observed difference in transfer time.

3. Trial Design

This was a completed, single-site pilot study with a parallel-group structure. The registry lists non-randomized allocation and no masking. Its title identifies SimPull as a primary means of lateral patient transfer. The record lists enrollment of 100 and gives a start date of 2023-11-16 and a primary completion date of 2024-08-14.

Two groups involved patient transfers after cardiac catheterization lab or electrophysiology lab procedures. In the standard-of-care group, nursing staff used current standard-of-practice lateral transfer methods to move the patient between beds. In the SimPull group, the transfer used the SimPull device. A third group consisted of clinicians, who completed a survey after conducting an intervention or standard-of-care procedure on participants. The registry does not describe how participants or clinicians were assigned to groups.

Non-randomized allocation matters when interpreting group comparisons. Random assignment can, in general, help balance measured and unmeasured participant characteristics across groups. Without it, group membership may be related to factors that also affect transfer time. The registry record does not explain whether the groups were matched, whether adjustment for baseline characteristics was planned, or whether other steps were taken to address confounding. It therefore does not support treating the two groups as equivalent except for the transfer method.

The record lists the study status as completed. It describes five outcome measures, including the primary time measure and secondary clinician survey outcomes, but lists no statistical analyses. Numerical results for the primary endpoint are not reported in the registry record. The protocol, analysis plan, participant flow, and detailed eligibility criteria are also not reported in the registry record. These omissions limit what can be reconstructed about how the study was carried out and how its data were intended to be analyzed.

The study is described as a pilot. A pilot can provide information about whether study procedures can be carried out and can generate preliminary estimates for later research. That role is distinct from confirming a treatment effect. The registry does not state the study’s sample-size justification or explain what conclusions the investigators intended to draw from the pilot.

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.

Before assignment: Only Group 1 and Group 2 were actual participants who were enrolled in the study. Data was only collected for Group 1 and Group 2. Group 3 consisted of clinicians (provided the intervention or standard of care to Group 1 and Group 2 participants). Group 3 did not receive any intervention nor were they enrolled in the study. Group 3 only participated in the post intervention/standard of care survey.

Overall Study

5. Baseline Characteristics

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

Population: Group 3 was not enrolled in the study. They participated in the evaluation of this intervention as providers. This group did not receive the study intervention nor standard of care, and no demographic data was collected from this group. Only data from Group 1 and Group 2 is reported.

6. Primary Endpoint

The registry lists the primary outcome as Time to Complete Lateral Transfer, measured over Baseline.

The primary endpoint is the average total time, measured in minutes, to complete a lateral transfer. The registry labels the summary measure as a mean with standard deviation and gives the timeframe as “Baseline.” It does not provide a numerical mean, standard deviation, group-level result, or statistical comparison.

Transfer time is used as a direct measure of the study’s stated efficiency question: how long it took to move a patient from one bed to another. A mean summarizes the group’s average recorded time. A standard deviation describes how spread out individual times are around that average. In general, looking at both can help distinguish a group with a relatively consistent set of times from one with more variation, even if their averages are similar.

Time is only one part of evaluating a transfer method. A shorter average time would not, by itself, describe whether clinicians found the method acceptable or whether safety concerns arose. The registry therefore also lists clinician satisfaction and survey responses about the likelihood of experiencing injury during transfers as secondary outcomes. The record does not report their numerical results, survey wording, or scoring approach.

The primary endpoint’s timeframe is recorded as “Baseline,” but the registry does not give further details about when timing began or ended, who recorded it, or whether the same procedure was followed in both groups. Those details matter for interpreting a time measurement: different definitions or recording practices can affect comparability. They are not reported in the registry record. With no posted endpoint values, the measure’s definition can be described, but the observed transfer times and their precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized by a mean and standard deviation. It does not report a statistical analysis for this outcome. The explanations below are general descriptions of how these methods and design features are commonly considered; they are not claims about an analysis performed in this study.

What a mean and standard deviation describe

A mean is the arithmetic average of recorded values. For transfer time, it would summarize the average duration in a group. The standard deviation describes variation among individual observations around the mean. It is not the same as a confidence interval: the standard deviation describes how dispersed the observations are, while a confidence interval describes uncertainty about an estimated quantity such as a group mean or a difference between group means.

Means and standard deviations can be informative when a continuous measure is reasonably represented by its average and spread. They can be affected by unusually high or low observations, and the shape of the data matters when choosing an analysis. The registry does not report the distribution of transfer times, individual observations, or any checks of statistical assumptions. It is therefore not possible to determine whether a particular model would fit the observed data well.

Why the non-randomized comparison needs caution

In general, randomization is intended to make study groups comparable, on average, with respect to factors that could influence outcomes. Here, allocation is listed as non-randomized. This means group differences may reflect both the transfer method and pre-existing differences between groups. Potential confounding is a design concern, not proof that the groups actually differed.

Analysts can sometimes address measured confounding through adjustment, matching, or other methods. Those approaches depend on appropriate information about relevant factors and on assumptions about how they relate to group assignment and the outcome. The registry does not report participant characteristics, a matching procedure, an adjustment model, or another strategy to address confounding. It also does not report how transfer procedures were allocated in practice. Thus, the record does not allow readers to evaluate whether a comparison was adjusted or how robust it might be.

How to read uncertainty measures

In general, an estimated difference between group means would summarize how far apart the group averages are, in the endpoint’s units. A confidence interval around that estimate would show the uncertainty associated with the estimate under the analysis assumptions. The interval’s width is important: a small estimated difference with considerable uncertainty has a different interpretation from a similar estimate with little uncertainty. Neither an estimate nor its interval establishes causation in a non-randomized study.

A significance test and its p-value are another form of statistical summary. In general, a p-value describes how compatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. The registry lists no analyses, so no p-value or confidence interval for the primary endpoint is available to assess.

What over-dispersion means in general

Over-dispersion is a general issue for some outcome models, especially models for counts or binary events, when observed variability is greater than a model expects. If it is ignored, uncertainty can be understated and statistical tests can appear more conclusive than warranted. The primary endpoint is continuous transfer time, summarized by a mean and standard deviation; the registry does not report that an over-dispersion model was used or needed. This concept should not be mistaken for a feature documented in this study.

How to read the planning illustrations

The sample-size section uses a stated planning framework: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set as a stated fraction of the observed effect. For non-time-to-event outcomes, its planning quantities are participants per arm. These are planning illustrations, not the study’s observed results or an account of the original design. The registry does not report the study’s own sample-size justification.

In general, a sample-size calculation estimates how many participants might be required to detect an effect under specified assumptions. Changing the assumed effect or variability can change the planning result. A calculation based on an observed effect is retrospective planning and should not be described as observed power. It does not show that the completed study had a particular probability of finding an effect, nor does it substitute for a confidence interval around the actual estimate. Since the registry record does not report the primary endpoint values, readers cannot evaluate the observed effect underlying these illustrations from the record alone.

Finally, the designation “pilot” should not be treated as a statistical method. A pilot can have feasibility aims, estimation aims, or other objectives, but the registry does not report a detailed statistical plan or sample-size rationale. The absence of listed analyses means that the record does not specify how investigators summarized the primary outcome, handled covariates, assessed assumptions, or addressed missing measurements.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Group 1: Standard of Care Transfer", "Group 2: SimPull Device Transfer")
n   <- c(50, 50)
m   <- c(33.4, 4.094)
sp  <- c(121.4, 1.688)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Group 1: Standard of Care Transfer  50  33.400  121.400  -1.101  67.901
CARM  Group 2: SimPull Device Transfer  50  4.094  1.688  3.614  4.574

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and identifies time to complete lateral transfer as the primary endpoint. It names clinician satisfaction and the number of clinician survey responses indicating that clinicians were very likely to experience injury during transfers as secondary outcomes. The record does not give numerical results for these outcomes, and it lists no statistical analyses.

Multiplicity arises when investigators make several statistical comparisons or evaluate several outcomes. In general, the more tests conducted, the greater the chance that at least one result appears statistically notable by chance, unless the analysis plan addresses this issue. Approaches can include defining a primary outcome in advance, adjusting significance thresholds, or interpreting secondary outcomes as exploratory. The registry does not report a multiplicity strategy, testing hierarchy, or analysis plan. It is therefore not possible to determine how the listed outcomes were intended to be analyzed together.

The record does not report how missing data were handled, whether any transfer-time measurements or survey responses were missing, or whether any participants were excluded from analyses. It also does not describe the population used for the primary analysis, such as whether all enrolled participants were intended to be included. The listed enrollment alone does not establish how many contributed data to any particular outcome.

For adverse events, the registry lists 50 participants at risk in each patient-transfer group and none at risk in the clinician group. Those entries are specific to the adverse-event record and do not establish the analysis population for other outcomes. Without further information about participant flow, missingness, and analysis populations, readers cannot assess whether the posted safety counts or any future outcome estimates include all relevant participants.

12. 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 record lists 50 participants at risk in the standard-of-care transfer group and 50 in the SimPull transfer group. In both groups, the registry records 0 serious adverse events, 0 other adverse events, and 0 deaths. The clinician group has 0 participants listed as at risk and 0 recorded events in these categories.

These entries are counts in the registry, not a complete characterization of safety. A recorded zero means that no event was entered for that category in the posted record; it does not prove that the event is impossible or that risk is absent. The registry does not provide event definitions, monitoring procedures, follow-up duration, or narratives describing how events were assessed. It also does not report clinician survey results about injury likelihood.

The two patient-transfer groups are not randomized, so the safety counts should not be read as a randomized comparison. The record does not provide a statistical comparison or uncertainty interval for adverse events. These figures can be reported descriptively, but they do not establish that the groups had equivalent safety or that either transfer method was safer.

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

This registry record describes a completed pilot study comparing two approaches to lateral patient transfer in separate, non-randomized groups. The primary question concerned the average time to complete a transfer. One group used standard-of-care methods and another used the SimPull device. The record also describes clinician surveys and lists satisfaction and perceived likelihood of injury among secondary outcomes.

What the posted record does show is the study structure, its primary outcome definition, its non-randomized allocation, and the adverse-event counts entered for the groups. What it does not show is the numerical result for transfer time. The registry record does not report group means, standard deviations, a difference between groups, a confidence interval, or a statistical test. Numerical results for the clinician outcomes are also not reported.

As a result, readers cannot use this record to determine whether the observed average transfer time was shorter in either group, how large any difference was, or how precise an estimate might be. Even with those estimates, a non-randomized comparison would require careful consideration of possible differences between groups. The registry does not report enough detail about group assignment, baseline characteristics, or analysis methods to assess those issues.

The zero adverse-event counts should also be interpreted narrowly. They describe the entries in the registry and do not show that the risk of an event is absent. The record does not give the follow-up details or safety definitions needed for a broader assessment.

The planning illustrations are not evidence of an observed treatment effect and should not be interpreted as observed power. They illustrate assumptions for planning and are distinct from trial results. Overall, this record can help readers understand what was studied and what information was registered, but it does not supply the outcome estimates needed to judge the size, precision, or cause of any difference between transfer methods.

14. Why This Trial Matters Statistically

This study raises a practical statistical question: how should researchers compare a continuous process measure when participants are allocated non-randomly? Transfer duration is straightforward to express in minutes, and a mean with a standard deviation offers a familiar summary. But the simplicity of the measurement does not remove the challenges of group comparability, uncertainty, and incomplete reporting.

The non-randomized design makes it important to distinguish description from causal inference. A group average can describe the transfers observed in that group. A contrast between group averages may describe an association, but attributing that contrast to the transfer method requires stronger assumptions and relevant information about other factors. The registry does not report the allocation process, baseline characteristics, or analysis plan needed to evaluate those assumptions.

The pilot context also matters. Pilot studies can help establish whether study procedures are workable and can inform later studies. Their estimates may be uncertain, and the registry does not explain the intended role of this pilot’s results or report its sample-size justification. The planning illustrations on the page are useful for understanding how assumptions relate to planning, but they are not a substitute for the trial’s observed estimates.

Finally, this record demonstrates why outcome reporting is essential for statistical interpretation. Defining a primary endpoint and listing study groups tells readers what investigators intended to examine. Without the outcome values, uncertainty measures, and analysis details, readers cannot assess the magnitude or precision of a comparison. The record remains informative about design and reporting, but its posted data do not answer the primary quantitative question.

15. 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 specific to this record constrain interpretation. First, the comparison was non-randomized, and the registry does not describe how patients entered either transfer group. It also does not report baseline characteristics or whether any adjustment was made. This leaves the comparability of the groups uncertain and limits causal conclusions.

Second, the primary endpoint is described as average transfer time in minutes, with a mean and standard deviation, but no numerical endpoint results are reported. The registry also gives the timeframe as “Baseline” without further explanation of how timing was defined, who recorded it, or whether the same measurement procedure was used across groups. These details are important to understanding the endpoint and its comparability.

Third, the registry lists no statistical analyses. The analysis plan, handling of missing data, analysis population, and approach to multiple outcomes are not reported in the registry record. The record names secondary clinician outcomes but does not report their results, survey wording, or scoring. It also does not give detailed eligibility criteria or participant characteristics.

Fourth, the safety record is limited to adverse-event counts. It does not provide event definitions, monitoring procedures, follow-up details, or narratives. The clinician group has no participants listed as at risk for those counts, so its zero entries should not be read as evidence about clinician outcomes or safety.

Finally, the record does not report the original sample-size justification. The planning illustrations are based on a stated framework and are not a substitute for that missing design information or for observed results. Taken together, these gaps mean that the study’s design can be described, but its primary comparison and the precision of that comparison cannot be assessed from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Evaluate SimPull for Lateral Patient Transfer — NCT05856123.
• Registry record last updated 2025-10-22; status last verified 2025-08.
• Results first posted 2025-10-22.
• 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.

19. Record Summary

The registry describes a completed, single-site, non-randomized pilot study of SimPull for lateral patient transfer. It lists enrollment of 100, with a start date of 2023-11-16 and a primary completion date of 2024-08-14. The two patient groups used either standard-of-care transfer methods or the SimPull device after a cardiac catheterization lab or electrophysiology lab procedure. Clinicians completed surveys after conducting an intervention or standard-of-care procedure.

The primary endpoint was mean time to complete a lateral transfer, measured in minutes. Clinician satisfaction and survey responses about likely injury during transfers were listed as secondary outcomes. The registry does not report numerical outcome results or statistical analyses. For the two patient-transfer groups, it records 0 serious adverse events, 0 other adverse events, and 0 deaths among 50 participants at risk in each group. These figures are descriptive registry entries and do not establish comparative safety.