Venous CatheterizationIDECHONCT02285712
Ultrasound-Guided Peripheral Intravenous Access by Critical Nurses.
A study testing Vascular ultrasound system in people with Venous Catheterization, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Catheterization
- What is being tested?
- Vascular ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jan 2017
- 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
- patient admitted in ICU
- patient not able to express his opposition
- central venous access that need to be removed
- need for a peripheral venous access
- no clinical instability
- no visible superficial vein due to: BMI> 30, fluid overload, previous history of IV drug abuse, previous history of chemotherapy ,
Who cannot join
- patient < 18 yo
- pregnancy
- patient under protective supervision
- need for a central venous access
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Nancy - Service de Réanimation Médicale Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses
Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.
- Conditions
- Venous Catheterization
- Being tested
- Vascular ultrasound system
- Keywords
- Peripheral venous catheter, ultrasound, nurse, Intensive Care Units
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular ultrasound systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Classical method of peripheral venous catheterization | No intervention | Classical method will be applied only on arm and forearm. |
| Ultrasound guided peripheral venous catheterization | Experimental | Nurse will use a vascular ultrasound system to orient the catheter toward the peripheral vein. Ultrasound method will be applied only on arm and forearm. Receives: Device: Vascular ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of peripheral venous catheterization attempts
Each day, only 3 attempts are allowed
Measured: up to day 2
Secondary outcomes (9)
Number of central lines removed
Measured: intraoperative
central venous catheter dwell time
defined period between insertion and removal of the central venous line
Measured: intraoperative
peripheral venous catheter dwell time
defined period between insertion and removal of the peripheral catheter with a maximum of 3 days.
Measured: intraoperative
number of central line catheter related infection
Measured: intraoperative
number of central line catheter related colonization
Measured: intraoperative
Diameter of the inserted peripheral venous catheter
at peripheral venous catheter insertion
Measured: day 0, or day 1 or day 2
patient satisfaction
assessed by an analogic scale
Measured: intraoperative
nurse satisfaction
assessed by a survey form
Measured: intraoperative
Proportion of peripheral venous catheter successful placement
Measured: at day 0, day 1, day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJan 2017
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 Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Kimmoun, M.D, Principal investigator, Intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285712
- Sponsor's protocol ID
- 2014-A01143-44
- Acronym
- IDECHO
- Status last verified
- Feb 2017
- First submitted
- 5 Nov 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.
PubMed 29886442
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses
- ClinicalTrials.gov ID
- NCT02285712
- Acronym / sponsor ID
- IDECHO / 2014-A01143-44
- Conditions
- Venous Catheterization
- Keywords
- Peripheral venous catheter, ultrasound, nurse, Intensive Care Units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Nov 2014 (estimated)
- 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.
Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical method of peripheral venous catheterization | No intervention | –Classical method will be applied only on arm and forearm. |
| Ultrasound guided peripheral venous catheterization | Experimental | Device: Vascular ultrasound systemNurse will use a vascular ultrasound system to orient the catheter toward the peripheral vein. Ultrasound method will be applied only on arm and forearm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient admitted in ICU
- patient not able to express his opposition
- central venous access that need to be removed
- need for a peripheral venous access
- no clinical instability
Key exclusion criteria (4 listed)
- patient < 18 yo
- pregnancy
- patient under protective supervision
- need for a central venous access
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 |
|---|---|---|
| Vascular ultrasound system | Device | Ultrasound guided peripheral venous catheterization |
Primary outcome
number of peripheral venous catheterization attempts
Time frame: up to day 2
Each day, only 3 attempts are allowed
9 secondary outcomes
Number of central lines removed
Time frame: intraoperative
central venous catheter dwell time
Time frame: intraoperative
peripheral venous catheter dwell time
Time frame: intraoperative
number of central line catheter related infection
Time frame: intraoperative
number of central line catheter related colonization
Time frame: intraoperative
Diameter of the inserted peripheral venous catheter
Time frame: day 0, or day 1 or day 2
patient satisfaction
Time frame: intraoperative
nurse satisfaction
Time frame: intraoperative
Proportion of peripheral venous catheter successful placement
Time frame: at day 0, day 1, day 2
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 1 Mar 2017.
- Derived from this study: PubMed 29886442Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.
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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.
Antoine Kimmoun, M.D principal investigator
Intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular ultrasound system in people with Venous Catheterization, run by Central Hospital, Nancy, France 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 6 inclusion and 4 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 1 Mar 2017. 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?
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 peripheral venous catheterization attempts (time frame: up to day 2). 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 NCT02285712, 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 1 Mar 2017.