Peripheral Vein Cannulation Guided by UltrasoundNCT05119985
Ultrasound Guided Peripheral Venous Cannulation in Patient Undergoing Elective Surgery Under General Anesthesia.
A study testing Peripheral vein cannulation and Cannulation without ultrasound in people with Peripheral Vein Cannulation Guided by Ultrasound, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vein Cannulation Guided by Ultrasound
- What is being tested?
- Peripheral vein cannulation and Cannulation without ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
Ústí nad Labem, Ústí nad Labem Region, 40001
About this study
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.
Read the 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.
- Being tested
- Peripheral vein cannulation, Cannulation without ultrasound
- Keywords
- ultrasound, vein, cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral vein cannulationProcedure or surgery
The target vein is directly identified by ultrasound, the procedure of peripheral venous catheter insertion is performed conventionally, without ultrasound guidance
Cannulation without ultrasoundProcedure or surgery
Cannulation is done the conventional way without any ultrasound use.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided cannulation | Active comparator | Ultrasound guided insertion of peripheral vein cannula. Receives: Procedure: Peripheral vein cannulation |
| Cannulation without ultrasound | Active comparator | Catheter insertion by conventional approach, without ultrasound guidance Receives: Procedure: Cannulation without ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Securing of Peripheral Vein on First Attempt
Comparing success rate of securing peripheral vein for first attempt in both methods.
Measured: 60 minutes
Secondary outcomes (3)
Number of Needed Attempts to Successful Securing of Peripheral
Compare number of attempts that was necessary to secure peripheral vein.
Measured: 60 minutes
Number of Complication After and During Securing Peripheral Vein
Compare complication rate after securing peripheral vein with both methods.
Measured: 24 hours
Time Needed to Secure Peripheral Vein
Compare time that was need to secure peripheral vein in both methods.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Dec 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vein Cannulation Guided by UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are divided by block randomization into two arms. Arm A peripheral vein cannulation with ultrasound guidance and Arm B conventional cannulation.
- Masking
- None (open label)
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119985
- Sponsor's protocol ID
- USG kanylace pžk
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Peripheral Venous Cannulation in Patient Undergoing Elective Surgery Under General Anesthesia.
- ClinicalTrials.gov ID
- NCT05119985
- Acronym / sponsor ID
- USG kanylace pžk
- Keywords
- ultrasound, vein, cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are divided by block randomization into two arms. Arm A peripheral vein cannulation with ultrasound guidance and Arm B conventional cannulation.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided cannulation | Active comparator | Procedure: Peripheral vein cannulationUltrasound guided insertion of peripheral vein cannula. |
| Cannulation without ultrasound | Active comparator | Procedure: Cannulation without ultrasoundCatheter insertion by conventional approach, without ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral vein cannulationThe target vein is directly identified by ultrasound, the procedure of peripheral venous catheter insertion is performed conventionally, without ultrasound guidance | Procedure or surgery | Ultrasound guided cannulation |
| Cannulation without ultrasoundCannulation is done the conventional way without any ultrasound use. | Procedure or surgery | Cannulation without ultrasound |
Primary outcome
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.
3 secondary outcomes
Number of Needed Attempts to Successful Securing of Peripheral
Time frame: 60 minutes
Number of Complication After and During Securing Peripheral Vein
Time frame: 24 hours
Time Needed to Secure Peripheral Vein
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral vein cannulation and Cannulation without ultrasound in people with Peripheral Vein Cannulation Guided by Ultrasound, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successful Securing of Peripheral Vein on First Attempt (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.