Development and Evaluation of an Algorithm for Vascular Access Management

NCT05935228 | Recruiting

• 1 other identifier: 2023-A00223-42
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peripheral Venous Access

Keywords

Difficult Intravenous Access (DIVA); Difficult Intravenous Access Scale (A-DIVA Scale); Algorithm; Peripheral venous catheter; Decision-making tree

Outcome Measures

Primary Outcomes (1)

• 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).

  20 months

Secondary Outcomes (9)

• 2. Number of participants who approve the co-constructed algorithm.

  8 months

• 3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm

  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)

  8 months and 16 months

• 5. Number of venipunctures performed per patient after implementation of the venous access difficulty score

  8 months

• Insertion technique used for catheter placement

  8 months ans 16 months

Study Arms (2)

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.

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.

Other: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers

Interventions

Implementation of the A-DIVA Scale OTHER

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

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 centers OTHER

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.

The experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Center Hospital Nancy

Vandœuvre-lès-Nancy, 54 500, France

RECRUITING

Related Publications (26)

• 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.

  PMID: 30057103 BACKGROUND

• van 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.

  PMID: 30032874 BACKGROUND

• Bauman 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.

  PMID: 19371518 BACKGROUND

• Adhikari 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.

  PMID: 20427786 BACKGROUND

• Bjorkander 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.

  PMID: 29992634 BACKGROUND

• Marsh 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.

  PMID: 34689013 BACKGROUND

• Liu 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.

  PMID: 23880981 BACKGROUND

• Bouaziz 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.

  PMID: 25829319 BACKGROUND

• Cai 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.

  PMID: 28484817 BACKGROUND

• Adams 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.

  PMID: 27397766 BACKGROUND

• Lockwood 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.

  PMID: 31437056 BACKGROUND

• Vinan-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.

  PMID: 31384213 BACKGROUND

• Loon 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.

  PMID: 27100437 BACKGROUND

• van 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.

  PMID: 30691137 BACKGROUND

• Bahl 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.

  PMID: 34789023 BACKGROUND

• Civetta G, Cortesi S, Mancardi M, De Pirro A, Vischio M, Mazzocchi M, Scudeller L, Bottazzi A, Iotti GA, Palo A. EA-DIVA score (Enhanced Adult DIVA score): A new scale to predict difficult preoperative venous cannulation in adult surgical patients. J Vasc Access. 2019 May;20(3):281-289. doi: 10.1177/1129729818804994. Epub 2018 Oct 16.

  PMID: 30324841 BACKGROUND

• Girotto C, Arpone M, Frigo AC, Micheletto M, Mazza A, Da Dalt L, Bressan S. External validation of the DIVA and DIVA3 clinical predictive rules to identify difficult intravenous access in paediatric patients. Emerg Med J. 2020 Dec;37(12):762-767. doi: 10.1136/emermed-2020-209658. Epub 2020 Oct 20.

  PMID: 33082150 BACKGROUND

• Santos-Costa P, Sousa LB, van Loon FHJ, Salgueiro-Oliveira A, Parreira P, Vieira M, Graveto J. Translation and Validation of the Modified A-DIVA Scale to European Portuguese: Difficult Intravenous Access Scale for Adult Patients. Int J Environ Res Public Health. 2020 Oct 17;17(20):7552. doi: 10.3390/ijerph17207552.

  PMID: 33080802 BACKGROUND

• Debillon T, Zupan V, Ravault N, Magny JF, Dehan M. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 Jul;85(1):F36-41. doi: 10.1136/fn.85.1.f36.

  PMID: 11420320 BACKGROUND

• Chooi CS, White AM, Tan SG, Dowling K, Cyna AM. Pain vs comfort scores after Caesarean section: a randomized trial. Br J Anaesth. 2013 May;110(5):780-7. doi: 10.1093/bja/aes517. Epub 2013 Feb 5.

  PMID: 23384734 BACKGROUND

• Laksonen RP Jr, Gasiewicz NK. Implementing a Program for Ultrasound-Guided Peripheral Venous Access: Training, Policy and Procedure Development, Protocol Use, Competency, and Skill Tracking. Nurs Clin North Am. 2015 Dec;50(4):771-85. doi: 10.1016/j.cnur.2015.07.010.

  PMID: 26596664 BACKGROUND

• Lamperti M, Biasucci DG, Disma N, Pittiruti M, Breschan C, Vailati D, Subert M, Traskaite V, Macas A, Estebe JP, Fuzier R, Boselli E, Hopkins P. European Society of Anaesthesiology guidelines on peri-operative use of ultrasound-guided for vascular access (PERSEUS vascular access). Eur J Anaesthesiol. 2020 May;37(5):344-376. doi: 10.1097/EJA.0000000000001180.

  PMID: 32265391 BACKGROUND

• Adhikari S, Schmier C, Marx J. Focused simulation training: emergency department nurses' confidence and comfort level in performing ultrasound-guided vascular access. J Vasc Access. 2015 Nov-Dec;16(6):515-20. doi: 10.5301/jva.5000436. Epub 2015 Jun 20.

  PMID: 26109540 BACKGROUND

• van Loon FH, Puijn LA, van Aarle WH, Dierick-van Daele AT, Bouwman AR. Pain upon inserting a peripheral intravenous catheter: Size does not matter. J Vasc Access. 2018 May;19(3):258-265. doi: 10.1177/1129729817747531. Epub 2018 Mar 4.

  PMID: 29772984 BACKGROUND

• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

  PMID: 25791983 BACKGROUND

• Slosse C, Manneville F, Ricci L, Ostermann A, Klein S, Bouaziz H, Ambroise-Grandjean G. Development and evaluation of an algorithm for peripheral venous catheter placement (ALCOV): protocol for a quasi-experimental study. BMJ Open. 2024 Jun 19;14(6):e078002. doi: 10.1136/bmjopen-2023-078002.

  PMID: 38904139 DERIVED

Study Officials

• Côme SLOSSE

  Center Hospital Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine OSTERMANN

CONTACT

03 83 85 28 52; a.ostermann@chru-nancy.fr

Côme SLOSSE

CONTACT

c.slosse@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigateur

Model Details: 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).

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: July 7, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 9, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)