- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05119985
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
Status
Completed
Intervention / Treatment
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.
Collaborators
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
Keywords
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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