PrehospitalNCT03709394
Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion
A study testing Full utrasound guidance, Partial ultrasound guidance and No ultrasound guidance in people with Prehospital, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial summary
This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehospital
- What is being tested?
- Full utrasound guidance, Partial ultrasound guidance and No ultrasound guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2017to 31 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service
Who cannot join
- Coma
- 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
- Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Emergency Medical Service of the Central Bohemian Region
Beroun, Central Bohemia
About this study
Official title: Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study
This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.
Read the detailed description
Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.
- Conditions
- Prehospital
- Being tested
- Full utrasound guidance, Partial ultrasound guidance, No ultrasound guidance
- Keywords
- ultrasound, peripheral venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full utrasound guidanceProcedure or surgery
The target vein is directly identified by portable ultrasound device and the complete procedure of peripheral venous cathether insertion is controlled by ultrasound guidance in real time
Partial ultrasound guidanceProcedure or surgery
The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance
No ultrasound guidanceProcedure or surgery
The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices
| Study group | Role | What they receive |
|---|---|---|
| Group A: Full utrasound guidance | Active comparator | Full utrasound guidance of cathether insertion. Intervention: Ultrasound portable device used for the identification of the target vein and for the ultrasound control of proper catheter placement during the procedure of peripheral venous cannula insertion. Receives: Procedure: Full utrasound guidance |
| Group B: Partial ultrasound guidance | Active comparator | Catheter insertion under partial ultrasound guidance. Intervention: Ultrasound portable device used only for the identification of the target vein, the catheter placement will be done by conventional approach. Receives: Procedure: Partial ultrasound guidance |
| Group C: No ultrasound guidance | Active comparator | Catheter insertion by conventional approach, without ultrasound guidance Receives: Procedure: No ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion
Frequency of the patients in which only one cannulation attempt was necessary
Measured: 60 minutes
Secondary outcomes (3)
Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts
Frequency of the patients in which peripheral venous catheter was inserted, irrespective of the number of attempts
Measured: 60 minutes
The number of attempts required for successful peripheral venous catheter insertion
The number of attempts required for successful peripheral venous catheter insertion
Measured: 60 minutes
Time required to introduce peripheral venous catheter
Time required to introduce peripheral venous catheter
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 posted17 Oct 2018
- Study start1 Jan 2017
- Primary completion31 May 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehospitalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized study
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709394
- Sponsor's protocol ID
- 2017-01
- Status last verified
- Jul 2020
- First submitted
- 8 May 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Completely anonymous sharing of IPD
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study
- ClinicalTrials.gov ID
- NCT03709394
- Acronym / sponsor ID
- 2017-01
- Conditions
- Prehospital
- Keywords
- ultrasound, peripheral venous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Oct 2018 (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 ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.
Detailed description
Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Group A: Full utrasound guidance | Active comparator | Procedure: Full utrasound guidanceFull utrasound guidance of cathether insertion. Intervention: Ultrasound portable device used for the identification of the target vein and for the ultrasound control of proper catheter placement during the procedure of peripheral venous cannula insertion. |
| Group B: Partial ultrasound guidance | Active comparator | Procedure: Partial ultrasound guidanceCatheter insertion under partial ultrasound guidance. Intervention: Ultrasound portable device used only for the identification of the target vein, the catheter placement will be done by conventional approach. |
| Group C: No ultrasound guidance | Active comparator | Procedure: No ultrasound guidanceCatheter insertion by conventional approach, without ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service
Key exclusion criteria (7 listed)
- Coma
- 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
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 |
|---|---|---|
| Full utrasound guidanceThe target vein is directly identified by portable ultrasound device and the complete procedure of peripheral venous cathether insertion is controlled by ultrasound guidance in real time | Procedure or surgery | Group A: Full utrasound guidance |
| Partial ultrasound guidanceThe target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance | Procedure or surgery | Group B: Partial ultrasound guidance |
| No ultrasound guidanceThe target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices | Procedure or surgery | Group C: No ultrasound guidance |
Primary outcome
Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion
Time frame: 60 minutes
Frequency of the patients in which only one cannulation attempt was necessary
3 secondary outcomes
Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts
Time frame: 60 minutes
The number of attempts required for successful peripheral venous catheter insertion
Time frame: 60 minutes
Time required to introduce peripheral venous catheter
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 21 Jul 2020.
- Individual participant dataSharing planned: Yes. Completely anonymous sharing of IPD
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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.
Roman Skulec, MD, PhD principal investigator
Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full utrasound guidance, Partial ultrasound guidance and No ultrasound guidance in people with Prehospital, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic 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 21 Jul 2020. 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?
Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.