NCT06518187

Brief Summary

This proposed study aims to fill this gap by investigating whether needle tip movement during catheter advancement is affected by whether the individual performing the insertion pushes the catheter off the needle themselves or if it is done by another person.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

July 8, 2024

Last Update Submit

January 14, 2026

Conditions

Keywords

IV Technique

Outcome Measures

Primary Outcomes (1)

  • Needle tip movement (displacement) in mm during initial advancement of a 16ga IV catheter off of its needle during simulated intravenous catheter insertion with three different catheter advancement techniques..

    If there is a significant difference in needle tip movement during catheter advancement related to technique of advancement (one handed, two handed, two person) a preferred technique(s) can be identified

    15 minutes

Study Arms (1)

Anesthesiology Healthcare providers/professionals

Investigating whether needle tip movement during catheter advancement is affected by whether the individual performing the insertion pushes the catheter off the needle themselves (either one handed or two handed) or if the catheter is advanced off the needle by another person.

Other: Assessing the impact of three different catheter advancement techniques on needle tip movement during intravenous insertion

Interventions

Each participant will perform 3 simulated IV catheter insertions using each of the specified techniques. Participants will use the instrumented 16ga IV catheter to insert into the peripheral vascular access simulator. Needle tip movement (from intent of catheter advancement to 5mm of advancement off the needle) will be measured with 0.2mm accuracy using the electromagnetic tracking technology of the simulator. Data collected will include needle movement after simulated vein punction and during initial catheter advancement off the needle (in mm) which will be recorded within the simulation program and output as a de-identified Excel file

Anesthesiology Healthcare providers/professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants for this study are Anesthesiology healthcare professionals/providers who perform IV catheter placement

You may qualify if:

  • years of age or older
  • Willing to consent to the study
  • has some experience placing IV catheters

You may not qualify if:

  • Subject refuses to consent
  • Younger than 18 years of age
  • No experience inserting IV catheters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health Shands

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Nikolaus Gravenstein, MD

    University of Florida Department of Aneshtesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 24, 2024

Study Start

October 15, 2024

Primary Completion

July 31, 2025

Study Completion

October 23, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations