Peripheral Venous AccessALCOVNCT05935228
Development and Evaluation of an Algorithm for Vascular Access Management
A study testing Implementation of the A-DIVA Scale and Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers in people with Peripheral Venous Access, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Venous Access
- What is being tested?
- Implementation of the A-DIVA Scale and Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2023to 9 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient inclusion criteria: adult patients, initially requiring at least one peripheral venous catheter (PVC), having given their consent for the study.
- Inclusion criteria for healthcare professionals: Nurses, specialized nurses (IADE) and physicians attached to the department.
Who cannot join
- Patient exclusion criteria :
- Minor patients
- Patients under curators or guardianship
- Patients who are non-communicative or unable to give consent
- Patients not requiring a peripheral venous catheter, polytrauma patients and patients in shock (septic, hemorrhagic, cardiogenic, spinal, specific to certain centers and equipped upstream)
- Patients who already have catheters on arrival.
- Exclusion criteria for healthcare professionals: any professional not attached to the department and other professional categories.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Côme SLOSSE contact
France1 site, 1 recruiting
- Recruiting
Center Hospital Nancy
Vandœuvre-lès-Nancy, 54 500
Amandine OSTERMANN, 03 83 85 28 52, a.ostermann@chru-nancy.fr
Côme SLOSSE, c.slosse@chru-nancy.fr
About this study
Official title: Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study
Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact.
To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner.
Read more
In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA.
Composed of five items (non-palpable and non-visible vein, diameter < 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score).
The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.
Read the detailed description
This is a mixed (quantitative and qualitative), multicentre, non-randomised, quasi-experimental, before-and-after, open, cross-sectional study, with control and experimental groups and comprising three phases. This division into three data collection phases allows detailed analysis of the targeted care procedure and avoids errors of assessment of the impact of the different tools introduced in the interventional phase (the A-DIVA Scale in phase 2, then the algorithm [composed of the A-DIVA Scale and the new decision-making tree (A-DIVA Tool] in phase 3).
Phase 1 (observational: 4 months): Description of the inclusion centers and collection of pre-intervention data.
This phase will provide information on the actual practices and organization in the inclusion centers. The main objective of this phase is to provide a detailed description of existing practices for peripheral venous catheter placement in the inclusion centers.
It consists of individual semi-directive explanatory interviews with healthcare professionals in the inclusion centers, and a collection of judgment criteria (excluding the feelings of patients and caregivers concerning the implementation of the DIVA score and the catheter placement algorithm). Collection of socio-demographic and clinical characteristics of patients and description of the care strategy implemented.
Phase 2 (interventional: 4 months - implementation of the A-DIVA Scale alone): Collection of data related to the isolated implementation of a systematic scoring of the A-DIVA score.
Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for DIVA) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire on the opinions of professionals on the use of the A-DIVA Scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a score for evaluating DIVA (compared with the initial practices clarified in phase 1).
Compared to phase 1: addition of systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and assessment of overall comfort.
Interphase: (8 months) Co-construction of the decision-making tree (the A-DIVA Tool).The interphase will allow to analyze the data collected in phase 1 and phase 2 and to develop the algorithm (composed by the A-DIVA Scale and the new A-DIVA Tool).
- Organization of a working group (including the investigator and volunteer caregivers): The data acquired in phase 1 and 2 will be described and presented to the professionals of each center in order to provide a basis for co-constructing the decision-making tree during the work groups.
- Validation of the algorithm according to the A-DIVA Scale based on literature data, research hypotheses and working group data. Presentation of the model to the care teams, validation of its acceptability and feasibility.
Phase 3 (interventional: 4 months - use of the algorithm composed of the A-DIVA Scale and the Co-constructed decision-making tree [The A-DIVA Tool]): Implementation and evaluation of the algorithm in the centers. The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.
- Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented (algorithm). Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.
- In relation to phase 2: implementation of the algorithm and collection of data to evaluate the implementation of the algorithm (e.g., frequency of use, optimal implementation (yes/no))
Post processing - valorization (10 months): Data analysis and scientific production:
The post-processing will allow the analysis of all the data (phase 3 versus phase 1 in particular), the production of reports and scientific articles and the writing of the final report of the ALCOV study.
- Analysis of the satisfaction questionnaire (proposed to caregivers at the end of the study) to complete the evaluation of the implementation of the algorithm.
- Description of the data (global and phase-by-phase) and analysis of the data to answer the formulated objectives, coding of the data from the interviews and satisfaction questionnaires, production of reports and scientific articles.
Representativeness of the sample:
- Throughout the collection process (phase 1,2 and 3) the representativeness of the sample will be assessed. The data collected for this purpose will be, for each patient who has received a peripheral venous line and who meets the inclusion criteria: Included: yes/no, if no: reason.
- Conditions
- Peripheral Venous Access
- Being tested
- Implementation of the A-DIVA Scale, Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers
- Keywords
- Difficult Intravenous Access (DIVA), Difficult Intravenous Access Scale (A-DIVA Scale), Algorithm, Peripheral venous catheter, Decision-making tree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the A-DIVA ScaleOther
Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for difficult intravenous access) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire of professionals' opinions on the use of the A-DIVA scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a tool for evaluating vascular access difficulties
Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centersOther
The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.
- Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented. Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Other | The control group will consist of patients included in phase 1. These are the patients from the "before" phase, i.e. before the implementation of the Difficult Intravenous Access Scale. Receives: Other: Implementation of the A-DIVA Scale |
| The experimental group | Experimental | The experimental group will consist of the patients included in phase 3. These are the patients from the "after" phases i.e after the implementation of the algorithm. Receives: Other: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Number of venipunctures performed per patient after implementation of the algorithm
Number of punctures performed per patient after implementation of the algorithm (collection according to a data grid filled in by the operator after the care).
Measured: 20 months
Secondary outcomes (9)
2. Number of participants who approve the co-constructed algorithm.
Co-construct a catheter placement algorithm based on the venous access difficulty score
Measured: 8 months
3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm
To meet this objective, caregivers' appreciation, use and feelings regarding the vascular access difficulties score and algorithm will be measured using a 23-item questionnaire scored on a 4-point Likert scale ("strongly disagree", "disagree", "agree", "strongly agree"). This questionnaire will also measure the effect of the vascular access difficulties score and the algorithm on practices.
Measured: 4 months
Patient pain score measured immediately after vascular puncture (phase of potential acute pain during catheter insertion) using a self-assessment tool (numerical scale ranging from 0: no pain; 10: maximum pain)
Describe how patients feel in terms of pain during care and overall comfort before and after the implementation of a catheter placement algorithm
Measured: 8 months and 16 months
5. Number of venipunctures performed per patient after implementation of the venous access difficulty score
Evaluate the effect of implementing the venous access difficulty score on the average number of venipunctures per patient
Measured: 8 months
Insertion technique used for catheter placement
Assessing operators' professional practices
Measured: 8 months ans 16 months
Number of operators required for catheter insertion
Assessing operators' professional practices
Measured: 8 months ans 16 months
Frequency of second-line referral to another practitioner
Assessing operators' professional practices
Measured: 8 months ans 16 months
Puncture result: success/failure
Assessing operators' professional practices
Measured: 8 months ans 16 months
Care strategies implemented in the event of difficulties encountered when inserting peripheral venous lines collected by the operator at the end of care.
Strategies implemented in the event of difficulties will be measured using a multi-modality question (several answers possible): Call another practitioner, use an alternative insertion technique, choose another type of venous line, give up
Measured: 8 months ans 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start5 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion9 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Peripheral Venous AccessStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a mixed (quantitative and qualitative), multicentre, non-randomised, quasi-experimental, before-and-after, open, cross-sectional study, with control and experimental groups and comprising three phases. This division into three data collection phases allows detailed analysis of the targeted care procedure and avoids errors of assessment of the impact of the different tools introduced in the interventional phase (the vascular access difficulty score \[VAD\] in phase 2, then the algorithm \[composed of the VAD score and the graded decision tree for management\] in phase 3).
- Masking
- None (open label)
- Enrolment
- 794 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SLOSSE Come, Central Hospital, Nancy, France
- Investigators
- Côme SLOSSE, Principal investigator, Center Hospital Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935228
- Sponsor's protocol ID
- 2023-A00223-42
- Acronym
- ALCOV
- Status last verified
- Apr 2026
- First submitted
- 9 May 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rickard CM, Marsh N, Webster J, Runnegar N, Larsen E, McGrail MR, Fullerton F, Bettington E, Whitty JA, Choudhury MA, Tuffaha H, Corley A, McMillan DJ, Fraser JF, Marshall AP, Playford EG. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial. Lancet. 2018 Aug 4;392(10145):419-430. doi: 10.1016/S0140-6736(18)31380-1. Epub 2018 Jul 26.
PubMed 30057103van Loon FHJ, Buise MP, Claassen JJF, Dierick-van Daele ATM, Bouwman ARA. Comparison of ultrasound guidance with palpation and direct visualisation for peripheral vein cannulation in adult patients: a systematic review and meta-analysis. Br J Anaesth. 2018 Aug;121(2):358-366. doi: 10.1016/j.bja.2018.04.047. Epub 2018 Jul 2.
PubMed 30032874Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
PubMed 19371518Adhikari S, Blaivas M, Morrison D, Lander L. Comparison of infection rates among ultrasound-guided versus traditionally placed peripheral intravenous lines. J Ultrasound Med. 2010 May;29(5):741-7. doi: 10.7863/jum.2010.29.5.741.
PubMed 20427786Bjorkander M, Bentzer P, Schott U, Broman ME, Kander T. Mechanical complications of central venous catheter insertions: A retrospective multicenter study of incidence and risks. Acta Anaesthesiol Scand. 2019 Jan;63(1):61-68. doi: 10.1111/aas.13214. Epub 2018 Jul 11.
PubMed 29992634Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, Mihala G, Chopra V, Rickard CM. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021 Dec;124:104095. doi: 10.1016/j.ijnurstu.2021.104095. Epub 2021 Sep 26.
PubMed 34689013Liu YT, Alsaawi A, Bjornsson HM. Ultrasound-guided peripheral venous access: a systematic review of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):18-23. doi: 10.1097/MEJ.0b013e328363bebc.
PubMed 23880981Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.
PubMed 25829319Cai EZ, Sankaran K, Tan M, Chan YH, Lim TC. Pen Torch Transillumination: Difficult Venepuncture Made Easy. World J Surg. 2017 Sep;41(9):2401-2408. doi: 10.1007/s00268-017-4050-3.
PubMed 28484817Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.
PubMed 27397766Lockwood J, Desai N. Central venous access. Br J Hosp Med (Lond). 2019 Aug 2;80(8):C114-C119. doi: 10.12968/hmed.2019.80.8.C114.
PubMed 31437056Vinan-Vega MN, Rahman MR, Thompson J, Ruppert MD, Patel RJ, Ismail A, Mousa S, Payne JD. Air embolism following peripheral intravenous access. Proc (Bayl Univ Med Cent). 2019 Jun 3;32(3):433-434. doi: 10.1080/08998280.2019.1609154. eCollection 2019 Jul.
PubMed 31384213Loon FHJV, Puijn LAPM, Houterman S, Bouwman ARA. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine (Baltimore). 2016 Apr;95(16):e3428. doi: 10.1097/MD.0000000000003428.
PubMed 27100437van Loon FHJ, van Hooff LWE, de Boer HD, Koopman SSHA, Buise MP, Korsten HHM, Dierick-van Daele ATM, Bouwman ARA. The Modified A-DIVA Scale as a Predictive Tool for Prospective Identification of Adult Patients at Risk of a Difficult Intravenous Access: A Multicenter Validation Study. J Clin Med. 2019 Jan 26;8(2):144. doi: 10.3390/jcm8020144.
PubMed 30691137Bahl A, Johnson S, Alsbrooks K, Mares A, Gala S, Hoerauf K. Defining difficult intravenous access (DIVA): A systematic review. J Vasc Access. 2021 Nov 17;24(5):904 - 910. doi: 10.1177/11297298211059648. Print 2023 Sep.
PubMed 34789023
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study
- ClinicalTrials.gov ID
- NCT05935228
- Acronym / sponsor ID
- ALCOV / 2023-A00223-42
- Conditions
- Peripheral Venous Access
- Keywords
- Difficult Intravenous Access (DIVA), Difficult Intravenous Access Scale (A-DIVA Scale), Algorithm, Peripheral venous catheter, Decision-making tree
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 794 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 9 Jun 2027 (estimated)
- First posted
- 7 Jul 2023 (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.
Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact.
To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner.
In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA.
Composed of five items (non-palpable and non-visible vein, diameter < 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score).
The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.
Detailed description
This is a mixed (quantitative and qualitative), multicentre, non-randomised, quasi-experimental, before-and-after, open, cross-sectional study, with control and experimental groups and comprising three phases. This division into three data collection phases allows detailed analysis of the targeted care procedure and avoids errors of assessment of the impact of the different tools introduced in the interventional phase (the A-DIVA Scale in phase 2, then the algorithm [composed of the A-DIVA Scale and the new decision-making tree (A-DIVA Tool] in phase 3).
Phase 1 (observational: 4 months): Description of the inclusion centers and collection of pre-intervention data.
This phase will provide information on the actual practices and organization in the inclusion centers. The main objective of this phase is to provide a detailed description of existing practices for peripheral venous catheter placement in the inclusion centers.
It consists of individual semi-directive explanatory interviews with healthcare professionals in the inclusion centers, and a collection of judgment criteria (excluding the feelings of patients and caregivers concerning the implementation of the DIVA score and the catheter placement algorithm). Collection of socio-demographic and clinical characteristics of patients and description of the care strategy implemented.
Phase 2 (interventional: 4 months - implementation of the A-DIVA Scale alone): Collection of data related to the isolated implementation of a systematic scoring of the A-DIVA score.
Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for DIVA) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire on the opinions of professionals on the use of the A-DIVA Scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a score for evaluating DIVA (compared with the initial practices clarified in phase 1).
Compared to phase 1: addition of systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and assessment of overall comfort.
Interphase: (8 months) Co-construction of the decision-making tree (the A-DIVA Tool).The interphase will allow to analyze the data collected in phase 1 and phase 2 and to develop the algorithm (composed by the A-DIVA Scale and the new A-DIVA Tool).
- Organization of a working group (including the investigator and volunteer caregivers): The data acquired in phase 1 and 2 will be described and presented to the professionals of each center in order to provide a basis for co-constructing the decision-making tree during the work groups.
- Validation of the algorithm according to the A-DIVA Scale based on literature data, research hypotheses and working group data. Presentation of the model to the care teams, validation of its acceptability and feasibility.
Phase 3 (interventional: 4 months - use of the algorithm composed of the A-DIVA Scale and the Co-constructed decision-making tree [The A-DIVA Tool]): Implementation and evaluation of the algorithm in the centers. The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.
- Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented (algorithm). Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.
- In relation to phase 2: implementation of the algorithm and collection of data to evaluate the implementation of the algorithm (e.g., frequency of use, optimal implementation (yes/no))
Post processing - valorization (10 months): Data analysis and scientific production:
The post-processing will allow the analysis of all the data (phase 3 versus phase 1 in particular), the production of reports and scientific articles and the writing of the final report of the ALCOV study.
- Analysis of the satisfaction questionnaire (proposed to caregivers at the end of the study) to complete the evaluation of the implementation of the algorithm.
- Description of the data (global and phase-by-phase) and analysis of the data to answer the formulated objectives, coding of the data from the interviews and satisfaction questionnaires, production of reports and scientific articles.
Representativeness of the sample:
- Throughout the collection process (phase 1,2 and 3) the representativeness of the sample will be assessed. The data collected for this purpose will be, for each patient who has received a peripheral venous line and who meets the inclusion criteria: Included: yes/no, if no: reason.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a mixed (quantitative and qualitative), multicentre, non-randomised, quasi-experimental, before-and-after, open, cross-sectional study, with control and experimental groups and comprising three phases. This division into three data collection phases allows detailed analysis of the targeted care procedure and avoids errors of assessment of the impact of the different tools introduced in the interventional phase (the vascular access difficulty score [VAD] in phase 2, then the algorithm [composed of the VAD score and the graded decision tree for management] in phase 3).
| Arm | Type | Receives |
|---|---|---|
| The control group | Other | Other: Implementation of the A-DIVA ScaleThe control group will consist of patients included in phase 1. These are the patients from the "before" phase, i.e. before the implementation of the Difficult Intravenous Access Scale. |
| The experimental group | Experimental | Other: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centersThe experimental group will consist of the patients included in phase 3. These are the patients from the "after" phases i.e after the implementation of the algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient inclusion criteria: adult patients, initially requiring at least one peripheral venous catheter (PVC), having given their consent for the study.
- Inclusion criteria for healthcare professionals: Nurses, specialized nurses (IADE) and physicians attached to the department.
Key exclusion criteria (7 listed)
- Minor patients
- Patients under curators or guardianship
- Patients who are non-communicative or unable to give consent
- Patients not requiring a peripheral venous catheter, polytrauma patients and patients in shock (septic, hemorrhagic, cardiogenic, spinal, specific to certain centers and equipped upstream)
- Patients who already have catheters on arrival.
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 |
|---|---|---|
| Implementation of the A-DIVA ScalePhase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for difficult intravenous access) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire of professionals' opinions on the use of the A-DIVA scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a tool for evaluating vascular access difficulties | Other | The control group |
| Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centersThe main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement. • Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented. Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort. | Other | The experimental group |
Primary outcome
1. Number of venipunctures performed per patient after implementation of the algorithm
Time frame: 20 months
Number of punctures performed per patient after implementation of the algorithm (collection according to a data grid filled in by the operator after the care).
9 secondary outcomes
2. Number of participants who approve the co-constructed algorithm.
Time frame: 8 months
3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm
Time frame: 4 months
Patient pain score measured immediately after vascular puncture (phase of potential acute pain during catheter insertion) using a self-assessment tool (numerical scale ranging from 0: no pain; 10: maximum pain)
Time frame: 8 months and 16 months
5. Number of venipunctures performed per patient after implementation of the venous access difficulty score
Time frame: 8 months
Insertion technique used for catheter placement
Time frame: 8 months ans 16 months
Number of operators required for catheter insertion
Time frame: 8 months ans 16 months
Frequency of second-line referral to another practitioner
Time frame: 8 months ans 16 months
Puncture result: success/failure
Time frame: 8 months ans 16 months
Care strategies implemented in the event of difficulties encountered when inserting peripheral venous lines collected by the operator at the end of care.
Time frame: 8 months ans 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 30057103Rickard CM, Marsh N, Webster J, Runnegar N, Larsen E, McGrail MR, Fullerton F, Bettington E, Whitty JA, Choudhury MA, Tuffaha H, Corley A, McMillan DJ, Fraser JF, Marshall AP, Playford EG. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial. Lancet. 2018 Aug 4;392(10145):419-430. doi: 10.1016/S0140-6736(18)31380-1. Epub 2018 Jul 26.
- Background: PubMed 30032874van Loon FHJ, Buise MP, Claassen JJF, Dierick-van Daele ATM, Bouwman ARA. Comparison of ultrasound guidance with palpation and direct visualisation for peripheral vein cannulation in adult patients: a systematic review and meta-analysis. Br J Anaesth. 2018 Aug;121(2):358-366. doi: 10.1016/j.bja.2018.04.047. Epub 2018 Jul 2.
- Background: PubMed 19371518Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
- Background: PubMed 20427786Adhikari S, Blaivas M, Morrison D, Lander L. Comparison of infection rates among ultrasound-guided versus traditionally placed peripheral intravenous lines. J Ultrasound Med. 2010 May;29(5):741-7. doi: 10.7863/jum.2010.29.5.741.
- Background: PubMed 29992634Bjorkander M, Bentzer P, Schott U, Broman ME, Kander T. Mechanical complications of central venous catheter insertions: A retrospective multicenter study of incidence and risks. Acta Anaesthesiol Scand. 2019 Jan;63(1):61-68. doi: 10.1111/aas.13214. Epub 2018 Jul 11.
- Background: PubMed 34689013Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, Mihala G, Chopra V, Rickard CM. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021 Dec;124:104095. doi: 10.1016/j.ijnurstu.2021.104095. Epub 2021 Sep 26.
- Background: PubMed 23880981Liu YT, Alsaawi A, Bjornsson HM. Ultrasound-guided peripheral venous access: a systematic review of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):18-23. doi: 10.1097/MEJ.0b013e328363bebc.
- Background: PubMed 25829319Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.
- Background: PubMed 28484817Cai EZ, Sankaran K, Tan M, Chan YH, Lim TC. Pen Torch Transillumination: Difficult Venepuncture Made Easy. World J Surg. 2017 Sep;41(9):2401-2408. doi: 10.1007/s00268-017-4050-3.
- Background: PubMed 27397766Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.
- Background: PubMed 31437056Lockwood J, Desai N. Central venous access. Br J Hosp Med (Lond). 2019 Aug 2;80(8):C114-C119. doi: 10.12968/hmed.2019.80.8.C114.
- Background: PubMed 31384213Vinan-Vega MN, Rahman MR, Thompson J, Ruppert MD, Patel RJ, Ismail A, Mousa S, Payne JD. Air embolism following peripheral intravenous access. Proc (Bayl Univ Med Cent). 2019 Jun 3;32(3):433-434. doi: 10.1080/08998280.2019.1609154. eCollection 2019 Jul.
- Individual participant dataSharing planned: No
Related trials for Peripheral Venous Access
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Recruiting
Peripheral Venous Access Management by Radiologic Technologists in Radiodiagnostic Procedure
Skill Development of Staff, Clinical Practice
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Not yet recruiting
Venipuncture Via Nurse-AI Collaboration
Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination, Peripheral Venous Access Establishment
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.
Côme SLOSSE contact
Côme SLOSSE principal investigator
Center Hospital Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of the A-DIVA Scale and Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers in people with Peripheral Venous Access, 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 2 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine OSTERMANN (03 83 85 28 52, a.ostermann@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Number of venipunctures performed per patient after implementation of the algorithm (time frame: 20 months). 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 NCT05935228, which also lists 27 linked publications.
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 29 Apr 2026.