Peripheral Venous CatheterizationVENSCORENCT02789046
DIFFICULT INTRAVENOUS ACCESS IN ADULTS (VENSCORE)
An observational study of Peripheral Venous Catheterization, run by University Hospital, Bordeaux at 16 sites in France.
Trial summary
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period. The main objective: the outcome of interest is defined as failure of cannulation on first attempt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Venous Catheterization
- What is being tested?
- peripheral intravenous catheterization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 3,300 participants
- Where
- 16 sitesFrance
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- 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
Study population: Patients undergoing peripheral intravenous placement just before a surgery will be enrolled. (the investigator does not assign specific interventions to the subjects of the study)
Who may be able to join
- patients >18 years old, undergoing peripheral IV placement just before a surgery in operating room
Who cannot join
- patients who refused IV placement; pregnant woman; induction of anesthesia with sevoflurane without venous access in place
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Centre Hospitalier d'Agen
Agen
Centre Médico-chirurgical Wallerstein
Arès
Centre Hospitalier de la Cote Basque
Bayonne
Clinique Saint Augustin Bordeaux
Bordeaux, 33000
Institut Bergonié
Bordeaux, 33000
Centre hospitalier Universitaire de Bordeaux
Bordeaux
Hôpital d'instruction des Armées Robert Picqué
Bordeaux
Centre Hospitalier de Dax
Dax
Centre Hospitalier d'Arcachon
La Teste-de-Buch, 33260
Centre Hospitalier Sud Gironde
Lagon, France
Centre Hospitalier de Libourne
Libourne
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40000
Centre Hospitalier de Pau
Pau
Centre Hospitalier de Périgueux
Périgueux
CHU Saint Pierre
Saint Pierre La Réunion, Ile de La Réunion
Centre Hospitalier de Tahiti
Tahiti
About this study
Official title: DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.
The main objective: the outcome of interest is defined as failure of cannulation on first attempt.
The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)
Read the detailed description
Objectives:
To define a difficult intravenous access score in adult during the preoperative period Methods Multicenter, Observational prospective study
Patients:
patients >18 years old, undergoing peripheral IV placement just before a surgery in operating room excision criteria: pregnant woman, induction of anesthesia with sevoflurane, Predictor variables include: history of patient (age,BMI, Fitzpatrick skin type, cancer, ICU stay, burn, diabetes, kidney disease, anxiety of patient...) , operator experience characteristics( years since graduation, years of anesthesiology experience, IVs started per month), type of catheter and place of catheterization),and postcatheterization data (success on fist attempt yes or no, number of total attempts until success...)
- Conditions
- Peripheral Venous Catheterization
- Being tested
- peripheral intravenous catheterization
- Keywords
- adult, vascular access, preoperative period, peripheral venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral intravenous catheterizationProcedure or surgery
success or failure intravenous placement on first attempt and factors associated with failed intravenous catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
failure intravenous placement on the first attempt
Measured: during the hour before surgery
Secondary outcomes (1)
risk factors associated with failure intravenous catheterization
Measured: during the hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous CatheterizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789046
- Sponsor's protocol ID
- CHUBXSAR32016-01
- Acronym
- VENSCORE
- Status last verified
- Mar 2019
- First submitted
- 24 May 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD
- ClinicalTrials.gov ID
- NCT02789046
- Acronym / sponsor ID
- VENSCORE / CHUBXSAR32016-01
- Conditions
- Peripheral Venous Catheterization
- Keywords
- adult, vascular access, preoperative period, peripheral venous catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Jun 2016 (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.
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.
The main objective: the outcome of interest is defined as failure of cannulation on first attempt.
The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)
Detailed description
Objectives:
To define a difficult intravenous access score in adult during the preoperative period Methods Multicenter, Observational prospective study
Patients:
patients >18 years old, undergoing peripheral IV placement just before a surgery in operating room excision criteria: pregnant woman, induction of anesthesia with sevoflurane, Predictor variables include: history of patient (age,BMI, Fitzpatrick skin type, cancer, ICU stay, burn, diabetes, kidney disease, anxiety of patient...) , operator experience characteristics( years since graduation, years of anesthesiology experience, IVs started per month), type of catheter and place of catheterization),and postcatheterization data (success on fist attempt yes or no, number of total attempts until success...)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing peripheral intravenous placement just before a surgery will be enrolled. (the investigator does not assign specific interventions to the subjects of the study)
Key inclusion criteria (1 listed)
- patients >18 years old, undergoing peripheral IV placement just before a surgery in operating room
Key exclusion criteria (1 listed)
- patients who refused IV placement; pregnant woman; induction of anesthesia with sevoflurane without venous access in place
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 intravenous catheterizationsuccess or failure intravenous placement on first attempt and factors associated with failed intravenous catheterization | Procedure or surgery | – |
Primary outcome
failure intravenous placement on the first attempt
Time frame: during the hour before surgery
1 secondary outcome
risk factors associated with failure intravenous catheterization
Time frame: during the hour before surgery
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 4 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Venous Catheterization, run by University Hospital, Bordeaux at 16 sites 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 1 inclusion and 1 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
failure intravenous placement on the first attempt (time frame: during the hour before surgery). 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 4 Apr 2019.