Catheterization, PeripheralKatECHONCT04856826
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
A study testing ultrasound guidance and therapeutic communication in people with Catheterization, Peripheral and Echography, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral, Echography, Hospital Units
- What is being tested?
- ultrasound guidance and therapeutic communication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2021to 1 Jun 2026
- 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
- Hospitalized in the post-emergency unit
- Requiring the placement of a venous catheter in the post-emergency unit
- Affiliation to social security or benefiting from such a scheme
- Informed and written consent signed
Who cannot join
- Protected person (art. L1121-5 to L1121-8 of the CSP)
- Patient included in another interventional study
- Patient already included for a first catheter placement in the post-emergency unit.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
La Tronche, 38700
Julie Duhoo, 0476767094, jduhoo@chu-grenoble.fr
About this study
Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.
- Conditions
- Catheterization, Peripheral, Echography, Hospital Units
- Being tested
- ultrasound guidance and therapeutic communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guidance and therapeutic communicationDevice
insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication
| Study group | Role | What they receive |
|---|---|---|
| echo guidance | Experimental | insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication Receives: Device: ultrasound guidance and therapeutic communication |
| conventional | No intervention | insertion of a peripheral venous catheter conventionally |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful placement of a venous catheter on the first attempt
percentage of successful placement of a venous catheter on the first attempt
Measured: within the hour after insertion of peripheral venous catheter
Secondary outcomes (10)
patient experience
not validated Satisfaction questionnaire and pain scale. score between 0 and 30 corresponding to high satisfaction
Measured: within the hour after insertion of peripheral venous catheter
number of attempts to insert a peripheral venous catheter
Average in each group of the number of attempts
Measured: within the hour during insertion of peripheral venous catheter
number of calls for a second nurse in the service
Average in each group of the number of service's interveners for a catheter placement
Measured: within the hour during insertion of peripheral venous catheter
number of calls to a nurse anesthetist
Average in each group of the number of external interveners
Measured: within the hour during insertion of peripheral venous catheter
location of the final placement site
Proportion of patients in each group according to the location of the final placement site
Measured: within the hour during insertion of peripheral venous catheter
the caliber of the catheter placed
Proportion of patients in each group according to the caliber of the catheter placed
Measured: within the hour during insertion of peripheral venous catheter
infectious or thromboembolic events
total number of infectious or thromboembolic events at the implantation site during the patient's stay in the post-emergency unit
Measured: 4 days
duration of catheter placement
Average duration, in minutes, of catheter placement in each group
Measured: within the hour during insertion of peripheral venous catheter
functional life of the catheter
functional life of the catheter, by group.
Measured: 4 days
Satisfaction of nursing staff
not validated Satisfaction questionnaire for nursing staff in the post-emergency unit . score between 0 and 55 corresponding to a high satisfaction
Measured: at the end of study inclusion, at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start5 Mar 2021
- Primary completion10 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 Catheterization, PeripheralStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine Dumanoir, Study chair, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856826
- Sponsor's protocol ID
- 38RC19.419
- Acronym
- KatECHO
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2021
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
- ClinicalTrials.gov ID
- NCT04856826
- Acronym / sponsor ID
- KatECHO / 38RC19.419
- Conditions
- Catheterization, Peripheral, Echography, Hospital Units
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Apr 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.
Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echo guidance | Experimental | Device: ultrasound guidance and therapeutic communicationinsertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication |
| conventional | No intervention | –insertion of a peripheral venous catheter conventionally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized in the post-emergency unit
- Requiring the placement of a venous catheter in the post-emergency unit
- Affiliation to social security or benefiting from such a scheme
- Informed and written consent signed
Key exclusion criteria (3 listed)
- Protected person (art. L1121-5 to L1121-8 of the CSP)
- Patient included in another interventional study
- Patient already included for a first catheter placement in the post-emergency unit.
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 |
|---|---|---|
| ultrasound guidance and therapeutic communicationinsertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication | Device | echo guidance |
Primary outcome
successful placement of a venous catheter on the first attempt
Time frame: within the hour after insertion of peripheral venous catheter
percentage of successful placement of a venous catheter on the first attempt
10 secondary outcomes
patient experience
Time frame: within the hour after insertion of peripheral venous catheter
number of attempts to insert a peripheral venous catheter
Time frame: within the hour during insertion of peripheral venous catheter
number of calls for a second nurse in the service
Time frame: within the hour during insertion of peripheral venous catheter
number of calls to a nurse anesthetist
Time frame: within the hour during insertion of peripheral venous catheter
location of the final placement site
Time frame: within the hour during insertion of peripheral venous catheter
the caliber of the catheter placed
Time frame: within the hour during insertion of peripheral venous catheter
infectious or thromboembolic events
Time frame: 4 days
duration of catheter placement
Time frame: within the hour during insertion of peripheral venous catheter
functional life of the catheter
Time frame: 4 days
Satisfaction of nursing staff
Time frame: at the end of study inclusion, at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- 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
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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.
Perrine Dumanoir study chair
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guidance and therapeutic communication in people with Catheterization, Peripheral and Echography, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Duhoo (+33476767094, jduhoo@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful placement of a venous catheter on the first attempt (time frame: within the hour after insertion of peripheral venous catheter). 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 NCT04856826, 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 19 Dec 2023.