- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518187
Investigating the Influence of Catheter Advancement Techniques on Needle Tip Movement During Intravenous Insertion
Study Overview
Status
Conditions
Detailed Description
Participant arrives at the simulation setting. Participant undergoes orientation and consent. This includes orientation to study procedure and equipment, explanation of catheter advancement techniques, and informed consent process. Following consent, participant fills out Participant Questionnaire. Total time required: Approximately 10 minutes.
Participant performs IV catheter insertion using 3 techniques: 1 (Self-advancement single hand), technique 2 (Self-advancement both hands), and technique 3 (second person assisted) in randomized order. Total time required: Approximately 5 minutes. Participant completes Participant Questionnaire. Participant's participation is concluded.
In this study, the observation to be carried out is the total distance of needle tip movement while performing the initial intravenous catheter advancement off of the needle using three different catheter advancement techniques including: Self-advancement with one hand; Self-advancement with two hands; Catheter advancement by another individual.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32608
- UF Health Shands
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Willing to consent to the study
- has some experience placing IV catheters
Exclusion Criteria:
- Subject refuses to consent
- Younger than 18 years of age
- No experience inserting IV catheters
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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..
Time Frame: 15 minutes
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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
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15 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nikolaus Gravenstein, MD, University of Florida Department of Aneshtesiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202400590
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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