Superior Venous Access, Midline vs Ultrasound IVs: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Superior Venous Access, Midline vs Ultrasound IVs (NCT03440944), a randomized na study. The primary outcome is Device Failures Within 72 Hours.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group clinical trial comparing an ultrasound-guided peripheral IV catheter with a midline catheter. The registry lists enrollment as 18 and trial status as terminated. It records no masking, meaning the study was not listed as blinded. The record does not give the reason for termination.

The ultrasound-guided peripheral IV catheter arm was assigned a standard ultrasound-guided peripheral IV catheter described as 4.88cm in length. The midline catheter arm was assigned a midline catheter described as 10cm in length. Details of the randomization process, including any sequence-generation or concealment procedures, are not reported in the registry record. Nor does the record report whether allocation was stratified or whether other design features were used to balance groups.

The primary outcome was device failure within 72 hours after placement. The stated assessment approach used medical record review and in-person visits with medical treatment teams and patients. The registry also lists IV catheter insertion time, total number of replacement catheters, catheter-related costs, and patient satisfaction as secondary outcomes. Results for these secondary outcomes are not reported in the registry record.

Although the trial was randomized, that design alone does not supply a result. The record lists no statistical analyses and does not present a single primary-outcome comparison. The sample-size justification, statistical analysis plan, and reason for stopping the trial are not reported in the registry record. These omissions limit what can be concluded about how the trial was intended to be analyzed and why it ended.

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:

Analysis population for the primary outcome, as defined in the registry: Patients who completed therapy within 72 hours were considered non-failure

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: Only patients that received Ultrasound Guided Peripheral IV or Midline Catheter underwent analysis.

6. Primary Endpoint

The registry lists the primary outcome as Device Failures Within 72 Hours, measured over 72 hours after device placement.

The primary endpoint was device failure within 72 hours after device placement. The registry defines failure as needing any device replaced or removed for clinical care. Patients who completed therapy within 72 hours were considered non-failures. Assessment was described as using medical record review and in-person visits with medical treatment teams and patients.

This endpoint focuses on whether the placed device remained usable for the relevant period without replacement or removal for clinical care. That makes it a direct measure of device performance over the stated follow-up window. It is distinct from the secondary measures of insertion time, replacement-catheter count, catheter-related costs, and patient satisfaction; those measures describe other aspects of the procedure and its consequences.

The registry describes the primary outcome as a total number and percentage of failures based on the assigned device. However, it does not report arm-level primary-outcome counts, percentages, or an inferential comparison. It also notes that the primary outcome has several categories or time points and was not reduced to a single comparison. As a result, the endpoint definition is available, but the posted record does not provide a single numerical result that answers the stated comparative question.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

Randomization assigns participants to study groups through a chance-based process. In general, it aims to reduce systematic differences between groups at the start of a trial, so that a later comparison is less vulnerable to selection effects. It does not guarantee that groups will be identical, especially in a small study, and it cannot compensate for missing outcome data or an unreported analysis. The registry identifies this trial as randomized and parallel-group, but details of the randomization procedure are not reported in the registry record.

What is the role of the primary endpoint?

A primary endpoint is the outcome selected to address the main research question. Here, the registry defines it as device failure within 72 hours after placement, with failure based on needing a device replaced or removed for clinical care. It states that patients who completed therapy within 72 hours were considered non-failures. A clear endpoint definition helps readers understand what event is being counted, but a definition is not a result. The record does not provide the primary-outcome comparison needed to estimate how the assigned groups differed.

How would a group comparison usually be interpreted?

For a binary endpoint such as whether a participant experienced device failure, an analysis could compare the event counts or proportions between groups. The interpretation depends on the analysis measure, its uncertainty, the follow-up definition, and how missing or incomplete observations are handled. In general, an effect estimate describes the observed contrast, while a confidence interval communicates its precision under the analysis assumptions. Neither an effect estimate nor a confidence interval for the primary outcome is reported in the registry record. No primary-outcome p-value is listed, and the record lists no statistical analyses.

Why does the observation window matter?

The endpoint is defined within 72 hours after device placement. A time window sets the period in which an event counts toward the outcome; events outside that period may not be part of the stated endpoint. The registry also describes completion of therapy within 72 hours as non-failure. That rule is part of the endpoint definition and matters when interpreting a future or posted analysis. The record does not explain how cases with incomplete follow-up, uncertain device status, or other unresolved outcome information were handled.

What do the sample-size illustrations mean?

The stated sample-size assumptions describe planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. They are planning exercises, not observed power and not evidence that the terminated trial had adequate power. In general, such illustrations ask how many participants per arm might be needed under specified assumptions to detect an effect of a stated size. Their interpretation depends on the underlying effect estimate and other assumptions. The registry record does not report its own sample-size justification. The primary comparison is not reported, so the posted record does not allow readers to judge how closely those planning assumptions correspond to a reported primary result.

What is not reported about the analysis?

The registry does not list an analysis of the primary endpoint. It also does not report a statistical analysis plan, the intended handling of missing data, adjustment for multiple outcomes, or the analysis population. Those details matter because analytical choices can affect which participants and events enter a comparison and how uncertainty is calculated. The record notes that the primary outcome has several categories or time points and was not reduced to a single comparison. Without a reported analysis, it is not possible to tell how the study team would have addressed that structure.

In general, methods should be interpreted in relation to the design and the data actually reported. Randomization supports a comparative design, while a defined outcome clarifies what the comparison concerns. Neither replaces the need for outcome counts, an analysis, and measures of uncertainty. For this trial, the available record supports a description of the intended comparison and endpoint, but not a quantitative conclusion about the primary question.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and several secondary outcomes: IV catheter insertion time, total number of replacement catheters, catheter-related costs, and patient satisfaction. When a study examines multiple outcomes or multiple time points, the chance of a nominally notable result arising by chance can increase if many comparisons are made. General methods for addressing this issue include defining a primary comparison in advance, adjusting inference for multiple testing, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or a statistical analysis plan.

The record also notes that the primary outcome has several categories or time points and was not reduced to a single comparison. It does not specify which comparisons were planned for those categories or time points. No primary-outcome analysis is listed, so there is no reported result to assess for multiplicity or to distinguish as confirmatory versus exploratory.

Missing-data methods and analysis populations are not reported in the registry record. In general, incomplete follow-up can affect an outcome comparison if participants with unknown device status are handled differently across groups or excluded from analysis. The endpoint definition describes patients who completed therapy within 72 hours as non-failures, but the record does not describe rules for other incomplete or uncertain cases. It also does not state whether analyses were intended to follow randomized assignment, include only participants with observed outcomes, or use another population definition.

These reporting gaps do not show that a particular analysis choice was made; they mean the record does not document one. They also prevent assessment of how missing outcomes, multiple endpoints, or the several primary-outcome categories and time points were handled.

11. 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.

Most frequent non-serious adverse event terms

The registry's adverse-event record lists serious events, other events, and deaths separately for the two assigned groups. It lists zero serious events and zero deaths in each group. For other events, it reports 6 in the ultrasound-guided peripheral IV catheter group and 1 in the midline catheter group, with 8 at risk listed for each group.

These are descriptive entries in the adverse-event record. They are not the primary device-failure results, and the registry does not report an analysis comparing these figures. The record does not provide further detail about the nature, timing, severity, or relationship to the assigned device of the other events. It also does not list any top serious-event terms.

In general, a count alone does not establish whether groups differ reliably. Interpretation depends on the event definitions, follow-up completeness, participant exposure, and statistical uncertainty. No such comparative safety analysis is reported in the registry record. The figures should therefore be read as the recorded counts, not as proof of a safety difference or equivalence.

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

The posted record establishes that a randomized, parallel-group trial was conducted to compare an ultrasound-guided peripheral IV catheter with a midline catheter. It specifies device failure within 72 hours after placement as the primary endpoint and defines what counted as failure. It also lists secondary outcomes related to insertion time, replacement catheters, costs, and patient satisfaction.

It does not establish which device had more failures, whether the groups had similar failure experience, or how precise any comparison would be. The registry record does not report primary-outcome counts or percentages by group, a single primary comparison, a confidence interval, or a p-value. The trial's terminated status and listed enrollment do not fill those gaps. The reason for termination is not reported.

The adverse-event entries provide separate descriptive counts: zero serious events and zero deaths in each group, and other-event counts of 6 and 1, with 8 at risk listed for each group. Those entries are not a substitute for the primary endpoint, and the registry does not report a comparative analysis of them. They cannot establish whether device failure differed between the assigned groups.

In general, a non-reported comparison cannot be interpreted as a null effect. Lack of a posted estimate is not evidence that the devices performed equally, and it is not evidence that one performed better. Likewise, randomization describes the design but does not by itself determine the result. A supported interpretation would require the primary outcome data, a defined analysis, and an account of uncertainty and missing observations.

The record is therefore informative about the question the investigators intended to study and the way they defined failure, but it does not provide the results needed to answer that question. The conclusions should remain limited to the trial description and the adverse-event entries actually recorded.

13. Why This Trial Matters Statistically

This trial raises a practical comparative question in vascular access: how ultrasound-guided peripheral IV catheters and midline catheters differ in device failure over the stated follow-up window. The registry makes the endpoint definition explicit, including the criterion that a device had to be replaced or removed for clinical care to count as a failure. Clear operational definitions are important because they determine which observations contribute to a clinical endpoint.

Statistically, the randomized parallel-group design is relevant because it is intended to support a comparison between assigned devices. Yet a design description is only one part of an evidence record. Readers also need the outcome counts, an analysis that matches the endpoint and design, and a measure of uncertainty. Without those, the intended comparison cannot be quantified or interpreted for precision.

The registry also lists outcomes beyond failure, including insertion time, replacement-catheter count, costs, and patient satisfaction. Those outcomes represent different dimensions of device use and would need clear definitions and appropriate analyses. The record does not report their results or how multiple outcomes were addressed.

The trial's termination and the absence of a single reported primary comparison underscore a broader statistical distinction: a study can be designed to answer a question without the public record containing enough results to answer it. The adverse-event counts contribute descriptive information, but they cannot stand in for the missing primary comparison. The record is therefore useful for identifying the intended question and endpoint, while also showing the limits of interpretation when outcome results and analysis details are not reported.

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 main limitation for interpreting this trial is that the registry record does not report a single primary-outcome comparison. It gives the failure definition and follow-up window but not arm-level primary failure counts or percentages, an effect estimate, a confidence interval, or a p-value. The stated question about comparative failure therefore cannot be answered from the posted record.

The record lists the trial as terminated and enrollment as 18, but the reason for termination is not reported. It does not provide the sample-size justification, a statistical analysis plan, or details of how randomization was implemented. It also does not report the analysis population or how missing and incomplete outcomes were handled. These omissions make it difficult to assess the intended analysis and its relationship to the data that might have been collected.

The registry notes that the primary outcome has several categories or time points and was not reduced to a single comparison. It does not specify how those categories or time points would have been analyzed, or how multiplicity would have been handled. Results for the listed secondary outcomes are also not reported.

The adverse-event entries are limited to counts and at-risk figures, with no detailed descriptions of the other events and no comparative statistical analysis. Those entries cannot resolve the missing primary-outcome information. Collectively, these reporting gaps constrain interpretation; they do not show that an unreported result was favorable, unfavorable, or null.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Superior Venous Access, Midline vs Ultrasound IVs — NCT03440944.
• Registry record last updated 2021-04-29; status last verified 2021-04.
• Results first posted 2021-04-29.
• 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.

18. Record Summary

The registry describes a randomized, parallel-group trial comparing an ultrasound-guided peripheral IV catheter with a midline catheter. It lists enrollment as 18 and status as terminated. Masking is listed as none. The primary endpoint is device failure within 72 hours after placement, defined as needing a device replaced or removed for clinical care.

The registry also lists insertion time, replacement-catheter count, catheter-related costs, and patient satisfaction as secondary outcomes. It does not report a single primary-outcome comparison or statistical analysis. The reason for termination, the sample-size justification, and the statistical analysis plan are not reported in the registry record. Adverse-event entries list zero serious events and zero deaths in each group; other-event counts are 6 and 1, with 8 at risk listed in each group. These entries do not replace the unreported primary comparison.