Ultrasound Guided Peripheral Venous Cannulation in Patient Undergoing Elective Surgery Under General Anesthesia.

December 18, 2024 updated by: Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
This study evaluates two different techniques for peripheral venous cannulation in operating theatre. Ultrasound guided insertion of peripheral cannula in comparison with conventional approach without any ultrasound guidance.

Study Overview

Detailed Description

Peripheral venous catheter placement is one of the key tasks of an anesthesiologist, which needs to be completed before surgery in general anesthesia. The reported success rate of peripheral venous cannulation, when performed in a conventional manner, without any special technical tools which facilitate finding the peripheral vein, is only 51% during the first trial. However, up to 7% of patients require more than three cannulation trials. Ultrasound guidance of peripheral venous catheter insertion may increase success rate and shorten time to securing peripheral cannula. However, this approach has not been verified in the setting of operating theatre so far. This project aims to set the role of ultrasound guided venous cannulation in operating theatre.

Study Type

Interventional

Enrollment (Actual)

860

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ústí nad Labem Region
      • Ústí Nad Labem, Ústí nad Labem Region, Czechia, 40001
        • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age over 18 years

Exclusion Criteria:

  • Age <18 years
  • Patient disagreement with the insertion of peripheral venous catheter
  • Disagreement of the patient with inclusion in a clinical trial
  • Contraindication of ultrasound examination of the venous system
  • Contraindication of the introduction of peripheral venous cannula on both upper limbs
  • Necessity of securing other vein access than peripheral
  • Contraindications of cannulation of peripheral vein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound guided cannulation
Ultrasound guided insertion of peripheral vein cannula.
The target vein is directly identified by ultrasound, the procedure of peripheral venous catheter insertion is performed conventionally, without ultrasound guidance
Active Comparator: Cannulation without ultrasound
Catheter insertion by conventional approach, without ultrasound guidance
Cannulation is done the conventional way without any ultrasound use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Successful Securing of Peripheral Vein on First Attempt
Time Frame: 60 minutes
Comparing success rate of securing peripheral vein for first attempt in both methods.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Needed Attempts to Successful Securing of Peripheral
Time Frame: 60 minutes
Compare number of attempts that was necessary to secure peripheral vein.
60 minutes
Number of Complication After and During Securing Peripheral Vein
Time Frame: 24 hours
Compare complication rate after securing peripheral vein with both methods.
24 hours
Time Needed to Secure Peripheral Vein
Time Frame: 60 minutes
Compare time that was need to secure peripheral vein in both methods.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • USG kanylace pžk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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