Skip to main content
NCBI home page
BMJ Open logoLink to BMJ Open
. 2026 Oct 22;16(10):e124434. doi: 10.1136/bmjopen-2026-124434

Ultrasound guidance versus near-infrared light versus the standard technique for first-attempt success of peripheral intravenous catheterisation in adults with difficult venous access in a medical imaging department (RÉUSSIR-VVP): protocol for a single-centre, three arms, randomised controlled trial

Guillaume Davy 1,2,3,✉, Florian Nassiri 1,2,3, Victor Dumas 2,3, Philippe Beyssen 1,2,3, Guillaume Herpe 1,2,3, Camille Alleyrat 4
PMCID: PMC13691894  PMID: 42914543

Abstract

Introduction

Peripheral intravenous catheterisation fails at the first attempt in about one in four adults and far more often in patients with difficult intravenous access (DIVA). Repeated attempts increase pain, anxiety, infection and extravasation risk, delay imaging, consume staff time and costs. Ultrasound guidance and near-infrared (NIR) vein illumination can each improve cannulation but no trial has directly compared them in a population defined by a validated DIVA Score. We aim to compare first-attempt cannulation success between the standard technique, ultrasound guidance and NIR illumination in adults with difficult venous access referred for imaging.

Methods and analysis

RÉUSSIR-VVP is a single-centre, prospective, randomised, open-label, superiority trial conducted in the CT units of Poitiers University Hospital, France. A total of 264 adult patients referred for a medical imaging examination requiring a contrast product and presenting an Adult DIVA Score≥2 will be randomised in a 1:1:1 ratio to receive either ultrasound guidance or NIR illumination or standard technique. The primary outcome is first-attempt successful catheterisation, defined as the placement of a functional catheter without immediate complication at the first skin puncture. Secondary outcomes include second-attempt successful catheterisation, total number of attempts, maximal pain, patient and operator satisfaction, time to successful catheterisation and catheter gauge.

Ethics and dissemination

The trial has been approved by the independent ethics committee ‘Comité de Protection des Personnes Nord-Ouest IV’ (date: 14 May 2024). The study will be conducted under European Medical Device Regulation 2017/745 and ISO 14155:2020. Findings will be published in a peer-reviewed journal and disseminated to participants and scientific societies.

Trial registration number

NCT06838364.

Keywords: ULTRASONOGRAPHY, Computed tomography, Nursing research, Nursing Care

STRENGTHS AND LIMITATIONS OF THIS STUDY.

  • The prospective use of the validated modified Adult Difficult Intravenous Access (A-DIVA) Score as an eligibility criterion enables direct comparison within a homogeneous difficult-access population.

  • Randomisation stratified by A-DIVA category (<4 vs ≥4) and operator experience is designed to make the results clinically transferable and to inform a personalised, score-driven choice of cannulation techniques.

  • An objective and clinically meaningful primary outcome (placement of a functional catheter without immediate complications at the first skin puncture) is assessed in a high activity, real-world imaging setting by the radiographers who routinely perform the procedure.

  • Blinding of operators and participants is not feasible because the assistive device is intrinsic to the technique.

  • The single-centre design in a CT imaging setting may limit generalisability to other settings and to operators with different training backgrounds.

Introduction

Peripheral intravenous catheterisation is among the most common invasive procedures in healthcare, with an estimated two billion peripheral intravenous catheters (PIVCs) inserted worldwide every year. PIVCs are required for the administration of fluids, blood products and medicines.1 In France, point-prevalence surveys consistently identify the PIVC as the single most frequent invasive device, present in approximately one in five hospitalised patients.2 Despite this ubiquity, PIVC insertion is technically demanding and fails at the first attempt in roughly one in four insertions, both in and out of hospital.3 4

The consequences of failed cannulation are substantial and accumulate with each additional attempt. Pain rises steeply with the number of punctures, from a mean Visual Analogue Scale Score of 2.9 at the first successful attempt to severe or unbearable levels by the fourth or fifth attempt.5 Each unsuccessful puncture introduces microorganisms and increases the risk of catheter-related bloodstream infection,6 7 a complication that, together with thrombophlebitis, drives appreciable morbidity, prolonged hospital stays and costs.8–11 Repeated attempts also increase the risk of contrast-medium extravasation, a recognised hazard of contrast-enhanced imaging that can require emergency surgical management.12 13 Beyond these clinical harms, difficult cannulation induces patient anxiety,14 erodes the patient–clinician relationship, exposes staff to blood and incurs considerable economic and opportunity costs in a context of acute workforce shortages.10 15

These harms are concentrated in patients with difficult intravenous access (DIVA). Risk factors for first-attempt failure include patient characteristics such as obesity, female sex, diabetes and chronic disease, vein characteristics such as poor visibility and small calibre, and operator experience, with first-attempt success plateauing only after roughly 1000 insertions.16 17 The definition of DIVA has historically been heterogeneous; the first evidence-based definition, proposed by Bahl et al from a systematic review, classifies a patient as having difficult access when a clinician has failed two or more attempts with traditional techniques, when physical examination is suggestive (no visible or palpable veins), or when there is a documented history of difficult access.18 Paterson’s review lists the tools used to assess the difficulty of venous access.19 To estimate the probability of success before the procedure, the modified Adult Difficult Intravenous Access (A-DIVA) Score assigns one point each to a known history of difficult access, a clinician’s prediction of difficulty, a non-visible vein, a non-palpable vein despite a tourniquet and the absence of a vein larger than 3 mm; first-attempt success declines steadily as the score rises. This five-item score has been validated prospectively in adults20 and is more widely used and better accepted by clinicians than alternatives, such as the eight-item Enhanced A-DIVA Score, which lacks external validation.21

Two assistive technologies are recommended by infusion-therapy standards to improve cannulation in patients who are difficult to cannulate: ultrasound guidance and near-infrared (NIR) vein illumination.22 NIR illumination projects NIR light onto the skin; light absorbed by haemoglobin in superficial vessels is mapped and reprojected in real time, helping to identify suitable veins and bifurcations without contact and with a short (about 2 hours) training time and no clinically significant learning curve.23 24 Evidence for NIR is strongest in children with difficult access.25 26 In adults the results are heterogeneous, with benefits demonstrated in selected difficult-access populations such as obese or diabetic patients and haemophilia patients, but no benefit when the device is used indiscriminately in unselected populations.27–29 A meta-analysis shows no significant effect on the first-attempt success rate of the infrared technique in DIVA patients.30 However, the devices have undergone technical improvements in recent years, influencing their performance. Ultrasound guidance allows direct, real-time visualisation of the vein and surrounding structures, avoids ionising radiation and is the reference technique for central venous access. Recent meta-analyses report safe or higher first-attempt success with ultrasound guidance than with the standard technique in DIVA adults and a reduction in direct complications, although the definition of DIVA varied between studies and none used the A-DIVA Score.31–35 Its principal limitations are device availability, the need for training and a learning curve of approximately 34 supervised insertions to reach a stable success rate.36

To our knowledge, only one randomised trial has directly compared these two technologies. Yalçınlı et al conducted a three-arm trial but did not use the Bahl definition or the A-DIVA Score, restricted operators to the most experienced nurses, used a previous-generation NIR device and reported an NIR success rate below that of the standard technique, contrary to the wider literature.37 No study has compared ultrasound guidance and NIR illumination as a function of the degree of venous-access difficulty measured by a validated score. There is currently no recommendation from scientific societies, nor robust evidence, to determine which of the two techniques is more effective in adults with difficult venous access.

We therefore designed the RÉUSSIR-VVP trial to compare the successful first-attempt cannulation between the standard technique, ultrasound guidance and NIR illumination in adults with difficult venous access, who require a peripheral catheter for an imaging examination. We hypothesise that there will be a difference in the success rate among the three techniques.

Methods and analysis

Study design and setting

RÉUSSIR-VVP is a single-centre, prospective, randomised, open-label and superiority trial with three parallel groups. Participants are randomly assigned in a 1:1:1 ratio. Randomisation is stratified according to the A-DIVA Score (<4 or ≥4) and the operator’s experience (<5 or ≥5 years). For the modified A-DIVA Score, the ≥4 threshold corresponds to the steepest drop in first-attempt success reported in the score’s validation cohort (55% for a score of 3 vs 14% for a score of 4, falling to 2% for a score of 5).20 The 5-year cut-off for operator experience is not a validated threshold in the literature. We use it as a pragmatic departmental benchmark, aligning with evidence that first-attempt success improves up to 1000 insertions and plateaus after.16 17 The trial is a clinical investigation of CE-marked medical devices used within their intended purpose, conducted in accordance with European Medical Device Regulation (EU) 2017/745 and ISO 14155:2020. It is conducted in the CT units of the medical imaging department of a French university hospital. The department operates three CT scanners eligible for inclusion; the scanner dedicated to emergencies is excluded to avoid delaying urgent care. The flow of participants through the trial is summarised in figure 1. The protocol items follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 recommendations38 for trial protocols; a populated SPIRIT schedule of enrolment, interventions and assessments is provided in figure 2.

Figure 1. Flow of participants through the RÉUSSIR-VVP trial. Adults referred for a medical imaging examination requiring a PIVC are screened, and those with a modified A-DIVA Score≥2 who consent are randomised 1:1:1 to the standard technique, ultrasound guidance or NIR illumination. The allocated technique is mandated for the first two attempts; a rescue strategy is permitted after two failed attempts to avoid any loss of chance. All randomised participants are analysed with a modified intention to treat. A-DIVA, Adult Difficult Intravenous Access; mITT, modified intention-to-treat; NIR, near-infrared; PIVC, peripheral intravenous catheters.

Flowchart of the RÉUSSIR-VVP trial showing 264 randomised adults allocated equally to standard landmark, ultrasound-guided or near-infrared illumination cannulation, each with rescue strategy after two failed attempts.

Open in a new tab

Figure 2. SPIRIT schedule of enrolment, interventions and assessments. Filled circles indicate the time point at which each procedure or assessment is performed, across the enrolment (day of imaging, before the procedure), allocation, the intervention (first and any rescue attempts) and the post-procedure period (with the catheter in situ, up to a maximum of 4 hours). The primary outcome (first-attempt success) is highlighted. A-DIVA, Adult Difficult Intravenous Access; NIR, near-infrared; NRS, Numerical Rating Scale.

SPIRIT schedule table mapping 15 assessments across enrolment, allocation, intervention and post-procedure timepoints. Most measures occur during intervention; pain, satisfaction and adverse events extend to post-procedure close-out.

Open in a new tab

Patient and public involvement

Patients and the public were not involved in the design and will not be involved in the conduct, reporting or dissemination plans of this trial. Future work building on these results is planned to include patient involvement, particularly in the assessment of the experience and the symbolic value of the procedure, which patients rate highly as a marker of care quality but which is not captured by the present outcomes.

Eligibility criteria

Eligibility criteria are summarised in table 1. Eligible patients are adults with a modified A-DIVA Score≥2 and referred for a medical imaging examination requiring a PIVC. Patients with a contraindication to peripheral catheterisation, those previously included, and those who benefit from enhanced legal protection (including pregnant or breastfeeding women) are not eligible. Eligible patients may be either outpatients attending a scheduled examination or inpatients referred from a ward, provided they meet the eligibility criteria; both are routinely referred to the CT units.

Table 1. Eligibility criteria.

Inclusion criteria Non-inclusion criteria

  • Aged 18 years or older

  • Appointment for a medical imaging examination with a medical prescription requiring a peripheral intravenous catheter

  • Modified A-DIVA Score≥2

  • Able and willing to comply with all study procedures

  • Affiliated with the French social-security system

  • Written informed consent

  • Contraindication to peripheral catheterisation: arteriovenous fistula arm; limb with an orthopaedic or vascular prosthesis; history of mastectomy, axillary lymph-node dissection or homolateral arm radiotherapy; paralysed limb; haematoma or wound at the puncture site; phlebitis or infectious focus

  • Previously included in the study

  • Enhanced legal protection: minors; persons deprived of liberty by judicial or administrative decision; persons in a health or social-care institution; pregnant or breastfeeding women; adults under legal guardianship; patients in critical situations.
Open in a new tab

A-DIVA, Adult Difficult Intravenous Access.

Randomisation and allocation

The randomisation list was generated before the beginning of the trial by a statistician using a computer-based random-number generator and implemented through a secure web-based system. After confirmation of eligibility and collection of written informed consent, participants are randomly allocated to receive either the standard technique, ultrasound guidance or NIR illumination in a 1:1:1 ratio, using a dedicated, password-protected website. Blinding of operators and participants is not feasible because the assistive device is an integral part of the cannulation technique. The operator who performs the procedure also assesses the primary outcome, an arrangement used in the large majority of comparative studies. In all three arms, the operator performs the procedure alone: the same radiographer handles the ultrasound probe or the NIR device (when allocated) and performs the venepuncture, without a dedicated assistant.

Interventions

All patients will receive proper asepsis according to the good-practice recommendations (the French National Authority for Health 2005 guidance and the French Society of Hospital Hygiene guidance on the prevention of infections related to peripheral vascular catheters).39 The allocated technique for cannulation is mandated for the first two attempts; the catheter gauge is left to the operator’s discretion.

Control arm (standard technique)

Cannulation is based on clinical assessment alone—visual inspection and palpation—supported by evidence-based vein-dilation manoeuvres (tourniquet and local pressure, gravity, tapping, muscle contraction and local warming).40

Ultrasound-guidance arm

Cannulation is performed with the assistance of an ultrasound system with a high frequency linear probe (GE Venue Fit with a L4-20t-RS XDclear linear probe, USA) under strict asepsis, following published recommendations.41 Identification of structures to avoid (arteries, nerves) provides an additional safety margin over the standard technique. Only operators who have completed training and validated 30 ultrasound-guided insertions may perform procedures in this arm.

NIR-illumination arm

Cannulation is performed with an NIR vein illuminator (Veinomène, Solycare; a CE-marked class I infrared vein-detection device, France) used as a complement to the standard technique. The device projects NIR light onto the skin and re-projects a real-time map of the superficial venous network, exploring veins to a depth of up to 8 mm. Only operators who have completed training and validated at least five NIR-assisted insertions may perform procedures in this arm.

Eligible operators are trained and reached the top of the learning curve in both techniques before they are allowed to enrol patients. This means that each radiographer can work on all three arms. All eligible operators are radiographers who are mobile across the CT scanners and therefore representative of routine practice in a university hospital. Training comprises a refresher on the standard technique, a short (about 2 hours) module for the NIR device and a longer (about 10 hours) ultrasound module combining theory, phantom-based simulation (consistent with the principle of ‘never the first time in a patient’) and a logbook of 5 supervised NIR insertions and 30 supervised ultrasound-guided insertions42 before participation. 14 radiographers are expected to participate.

To prevent any loss of chance, the randomised technique is mandated for the first two attempts. After two failed attempts, the operator may freely choose a rescue strategy—calling a colleague, changing technique, changing the catheter gauge or discussing abandonment and central venous access with the supervising physician.

Outcomes

The primary outcome is the proportion of participants with a successful first-attempt cannulation. Success is defined as the placement of a functional catheter without immediate complications at the first skin puncture attempt. The outcome is binary and assessed by the operator at the first attempt.

Secondary outcomes are: successful second attempt (defined identically, at the second skin puncture) when the first attempt failed; the total number of skin punctures; the maximal pain experienced by the patient during the attempts and assessed on a 0–10 Numerical Rating Scale; overall patient satisfaction and overall operator satisfaction, each assessed on a 0–10 Numerical Rating Scale; the time for a successful catheterisation, defined as the time from the end of equipment preparation to a successful cannulation and the catheter gauge at the successful attempt. If unsuccessful, indicate whether the next attempt was successful or whether the clinician needed to resort to an alternative approach.

The type of remedial action taken will be recorded: calling in another colleague, changing the technique (conventional method, infrared illumination or ultrasound guidance), changing the catheter size, abandoning the VVP placement or calling a doctor for a central venous line.

Data collection and management

Eligibility is assessed and informed consent obtained by the investigating radiographer on the day of the imaging examination, after a 15-minute reflection period. Data are recorded prospectively in a validated electronic case report form (Ennov Clinical) developed by the Platform for Methodology, Biostatistics and Data Management of the Poitiers University Hospital, with built-in consistency checks and a full audit trail. Recorded variables include patient age and sex, A-DIVA Score, pain and satisfaction scores; number of cannulation attempts, an attempt-by-attempt description of any rescue strategy, its type and the catheter gauge used. Data sources are held by the investigator, who guarantees direct access to monitoring, audit and inspection. Risk-based monitoring by a sponsor-mandated clinical research associate verifies consent, protocol compliance and data quality. Data are pseudonymised, processed in accordance with the EU General Data Protection Regulation and the French reference methodology MR-001 and archived for 15 years after the end of the investigation.

No independent DMC has been established for this trial. The benefit–risk balance is considered favourable, as both devices are CE-marked medical devices used within their intended purpose, no pharmacological agents are administered and anticipated harms are rare, transient and well characterised in the literature. The follow-up is limited to a single outpatient session of up to 4 hours, with no extended exposure requiring interim safety review. Adverse events, device issues and any unanticipated safety findings are reported to the sponsor and competent authority according to EU Medical Device Regulation 2017/745, ensuring ongoing regulatory oversight. No interim efficacy analysis is planned.

Statistics

Sample size

According to the study reported by Yalçınlı et al, the proportion of successful first-attempt catheterisation is 62.2% for the standard technique, 58.9% for NIR illumination and 78.9% for ultrasound guidance.37 To detect an absolute difference of 20% in our trial (78.9% vs 58.9%), with a two-sided type 1 error of 5% and a power of 80%, we plan to randomise 264 patients (88 per arm), considering 5% of randomised patients who will not be analysed (missing primary outcome or post-randomisation consent withdrawal).

Statistical analysis

Analyses will be performed based on the modified intention-to-treat set: all randomised patients, excluding participants who failed to meet major entry criteria43 and participants with missing primary outcomes. Missing data will be reported but no imputation will be performed (analyses performed on a complete case basis).

Baseline characteristics and outcomes will be summarised in each group and marginally. Continuous covariates will be summarised as mean and SD or median and IQR according to their distribution. Frequencies and percentages of patients in each category will be presented for categorical covariates. The time for a successful catheterisation will be summarised using the Kaplan-Meier estimator. According to Consolidated Standards of Reporting Trials (CONSORT) guidelines,44 baseline characteristics will not be tested for between-arm differences.

The primary outcome (successful first-attempt PIVC insertion) will be compared across the three arms using a logistic regression adjusted with stratification factors: A-DIVA Score (≥4 vs <4) and operator experience (<5 vs ≥5 years). Successful second-attempt PIVC insertion will be analysed using the same method. Time for catheterisation will be compared using a Cox proportional hazard model adjusted with stratification factors. Secondary continuous outcomes (number of attempts, maximal pain, patient and operator satisfaction and catheter gauge) will be compared using generalised linear models adjusted with stratification factors. Exploratory subgroup analyses will be conducted to investigate the interaction between A-DIVA Score and the technique used (standard, ultrasound or NIR). These subgroup analyses will focus on the primary outcome (successful first-attempt PIVC insertion) and the catheter gauge used during successful PIVC insertion. P values, ORs, HRs and regression coefficients relative to the randomisation arm will be reported. Two-sided p values<5% will be considered statistically significant. The statistical analyses related to the secondary outcomes will be considered as exploratory results with a risk of false positives. Analyses will be performed using R software (R Foundation, Vienna, Austria).

Ethics and dissemination

Ethics

The sponsor is the Poitiers University Hospital. The trial is conducted in accordance with EU Medical Device Regulation 2017/745, ISO 14155:2020 good clinical practice and the Declaration of Helsinki. This research was initially approved by the independent ethics committee of the Comité de Protection des Personnes Nord-Ouest IV (protocol version 2 dated 15 May 2024) (national identifier ID-RCB 2024-A00829-38). Substantial amendment #1 broadened eligibility from CT only to any medical imaging examination requiring a peripheral catheter, and extended the recruitment period; the present protocol corresponds to the amended version (version 3 dated 11 March 2026). The trial is registered at ClinicalTrials.gov (NCT06838364).

Written informed consent is obtained from every participant before any trial-related procedure. Substantial amendments are submitted to the competent authority and ethics committee before implementation.

Dissemination

The investigators are committed to publishing the results—whether positive, negative or inconclusive—in a peer-reviewed journal, in accordance with the International Committee of Medical Journal Editors recommendations and the CONSORT statement, and to reporting them to the competent authority and, on request, to participants. The final clinical investigation report will be submitted within the regulatory timelines, and a summary understandable to the public will be made available.

The full trial protocol is available as this manuscript, which constitutes the protocol publication, and is accessible via the ClinicalTrials.gov record (NCT06838364). A detailed statistical analysis plan (SAP) will be written by a statistician and will be approved by the principal investigator before the database locking and prior to any analysis of the data. The validated SAP will be loaded on the ClinicalTrials.gov record.

Discussion

Placing peripheral venous access in a strategic way has the potential to significantly increase the initial success rate. This approach could reduce pain, anxiety, infection risk, extravasation, delays in care and staff time, while also reducing costs.

The effectiveness of these techniques depends on the patient’s venous access challenges. By categorising the A-DIVA Score, the success rate can be examined based on the complexity of venous access. This is important in practice, as a more time-consuming and costly technique may not be sustainable if it does not provide enough value. The time indicators could serve as preliminary data for a future health economic study. If an attempt fails, the data collected will guide healthcare professionals towards a particular method, indicating the confidence they have in these techniques during the most challenging times.

The strengths of this trial include its randomised design and the gold standard procedure considered as a control group, which together enhance internal and external validity. The medical imaging department in question has a considerable workload in relation to peripheral venous access procedures. All relevant healthcare professionals are trained and experienced in these techniques.

However, several limitations should be acknowledged. First, the open-label design may introduce a performance bias. It is mitigated by several measures: the primary outcome is defined objectively and all operators received standardised training before their first inclusion. Second, the sample size relies on a single external trial with acknowledged methodological limitations, which could lead to insufficient statistical power. Third, contrast-medium extravasation is a rare but not exceptional complication of contrast-enhanced CT: large cohort studies report incidence rates of approximately 0.1–0.3% of injected examinations (0.23% in 142 651 scans; 0.11% in 378 082 scans, declining from 0.18% in 2017 to 0.07% in 2023; 0.27% in 1 43 556 patients; 0.24% in 57 528 patients),45–48 a frequency too low for our planned sample size to detect a between-arm difference with adequate power. A dedicated, adequately powered study or pooled meta-analysis would be needed to formally test whether a technique with higher first-attempt success also reduces extravasation risk.

Trial status

The current protocol is version 3 dated 11 March 2026, which incorporates substantial amendment #1. The trial is currently recruiting patients. The inclusion started on 8 April 2025 and the number of patients included to date (21 May 2026) is 41. This pace is slower than planned: the flow of patients meeting the modified A-DIVA≥2 threshold among those referred to the CT units has been lower than anticipated, and radiographer availability trained across all three arms has at times been limited by competing clinical workload; consent refusal has not been a material factor. The recruitment period has been extended accordingly (substantial amendment MS01).

Acknowledgements

The authors thank the tomodensitometry radiographer team of the department of Poitiers University Hospital for their contribution to the conduct of this trial. We would like to thank the leading radiography managers: Ms Sandrine Bruneteau for managing the bidding process and Mr Pierre-Edouard Bregerie for his involvement in organising this project.

Footnotes

Funding: This work was supported by two internal funding calls of Poitiers University Hospital (France): the 2021 ‘Commission Innovation’ call, which funded the ultrasound and near-infrared devices, and the 2022 ‘Fonds Aliénor’ call, an endowment fund of the sponsor. Neither internal call issued an external grant or award reference number.

Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2026-124434).

Patient consent for publication: Consent obtained directly from patient(s).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

References

  • 1.Ponsoye M, Espinasse F, Coutte L, et al. Utilisation des cathéters veineux: lesquels choisir, comment prévenir leurs complications? La Revue de Médecine Interne. 2021;42:411–20. doi: 10.1016/j.revmed.2020.10.385. [DOI] [PubMed] [Google Scholar]
  • 2.Santé publique France Enquête nationale de prévalence des infections nosocomiales et des traitements anti-infectieux en établissements de santé, mai-juin 2017. 2019:270.
  • 3.Lapostolle F, Catineau J, Garrigue B, et al. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007;33:1452–7. doi: 10.1007/s00134-007-0634-y. [DOI] [PubMed] [Google Scholar]
  • 4.Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005;34:345–59. doi: 10.1016/j.hrtlng.2005.04.002. [DOI] [PubMed] [Google Scholar]
  • 5.van Loon FH, Leggett T, Bouwman AR, et al. Cost-utilization of peripheral intravenous cannulation in hospitalized adults: An observational study. J Vasc Access. 2020;21:687–93. doi: 10.1177/1129729820901653. [DOI] [PubMed] [Google Scholar]
  • 6.Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006;81:1159–71. doi: 10.4065/81.9.1159. [DOI] [PubMed] [Google Scholar]
  • 7.Marsh N, Larsen EN, Ullman AJ, et al. Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis. Int J Nurs Stud. 2024;151:104673. doi: 10.1016/j.ijnurstu.2023.104673. [DOI] [PubMed] [Google Scholar]
  • 8.Mermel LA. Short-term Peripheral Venous Catheter-Related Bloodstream Infections: A Systematic Review. Clin Infect Dis. 2017;65:1757–62. doi: 10.1093/cid/cix562. [DOI] [PubMed] [Google Scholar]
  • 9.Tagalakis V, Kahn SR, Libman M, et al. The epidemiology of peripheral vein infusion thrombophlebitis: a critical review. Am J Med. 2002;113:146–51. doi: 10.1016/s0002-9343(02)01163-4. [DOI] [PubMed] [Google Scholar]
  • 10.Lim S, Gangoli G, Adams E, et al. Increased Clinical and Economic Burden Associated With Peripheral Intravenous Catheter-Related Complications: Analysis of a US Hospital Discharge Database. Inquiry. 2019;56:0046958019875562. doi: 10.1177/0046958019875562. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11.Marsh N, Webster J, Ullman AJ, et al. Peripheral intravenous catheter non-infectious complications in adults: A systematic review and meta-analysis. J Adv Nurs. 2020;76:3346–62. doi: 10.1111/jan.14565. [DOI] [PubMed] [Google Scholar]
  • 12.Wengström Y, Margulies A, European Oncology Nursing Society Task Force European Oncology Nursing Society extravasation guidelines. Eur J Oncol Nurs. 2008;12:357–61. doi: 10.1016/j.ejon.2008.07.003. [DOI] [PubMed] [Google Scholar]
  • 13.Wang CL, Cohan RH, Ellis JH, et al. Frequency, management, and outcome of extravasation of nonionic iodinated contrast medium in 69,657 intravenous injections. Radiology. 2007;243:80–7. doi: 10.1148/radiol.2431060554. [DOI] [PubMed] [Google Scholar]
  • 14.Fleckenstein FN, Böhm AK, Collettini F, et al. A prospective randomized controlled trial assessing the effect of music on patients’ anxiety in venous catheter placement procedures. Sci Rep. 2022;12:6922. doi: 10.1038/s41598-022-10862-0. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Carr PJ, Rippey JCR, Cooke ML, et al. From insertion to removal: A multicenter survival analysis of an admitted cohort with peripheral intravenous catheters inserted in the emergency department. Infect Control Hosp Epidemiol. 2018;39:1216–21. doi: 10.1017/ice.2018.190. [DOI] [PubMed] [Google Scholar]
  • 16.Rodríguez-Calero MA, Blanco-Mavillard I, Morales-Asencio JM, et al. Defining risk factors associated with difficult peripheral venous Cannulation: A systematic review and meta-analysis. Heart Lung. 2020;49:273–86. doi: 10.1016/j.hrtlng.2020.01.009. [DOI] [PubMed] [Google Scholar]
  • 17.Carr PJ, Rippey JCR, Cooke ML, et al. Factors associated with peripheral intravenous cannulation first-time insertion success in the emergency department. A multicentre prospective cohort analysis of patient, clinician and product characteristics. BMJ Open. 2019;9:e022278. doi: 10.1136/bmjopen-2018-022278. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Bahl A, Johnson S, Alsbrooks K, et al. Defining difficult intravenous access (DIVA): A systematic review. J Vasc Access. 2023;24:904–10. doi: 10.1177/11297298211059648. [DOI] [PubMed] [Google Scholar]
  • 19.Paterson RS, Schults JA, Slaughter E, et al. Review article: Peripheral intravenous catheter insertion in adult patients with difficult intravenous access: A systematic review of assessment instruments, clinical practice guidelines and escalation pathways. Emerg Med Australas. 2022;34:862–70. doi: 10.1111/1742-6723.14069. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20.van Loon FHJ, van Hooff LWE, de Boer HD, et al. 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;8:144. doi: 10.3390/jcm8020144. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 21.Civetta G, Cortesi S, Mancardi M, et al. EA-DIVA score (Enhanced Adult DIVA score): A new scale to predict difficult preoperative venous cannulation in adult surgical patients. J Vasc Access. 2019;20:281–9. doi: 10.1177/1129729818804994. [DOI] [PubMed] [Google Scholar]
  • 22.Nickel B. Peripheral Intravenous Access: Applying Infusion Therapy Standards of Practice to Improve Patient Safety. Crit Care Nurse. 2019;39:61–71. doi: 10.4037/ccn2019790. [DOI] [PubMed] [Google Scholar]
  • 23.Zeman HD, Lovhoiden G, Deshmukh H. Optimization of subcutaneous vein contrast enhancement. San Jose, CA: 2000. pp. 50–7. [Google Scholar]
  • 24.Vyas V, Sharma A, Goyal S, et al. Infrared vein visualization devices for ease of intravenous access in children: hope versus hype. Anaesthesiol Intensive Ther. 2021;53:69–78. doi: 10.5114/ait.2021.103515. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 25.Kuo C-C, Feng I-J, Lee W-J. The Efficacy of Near-Infrared Devices in Facilitating Peripheral Intravenous Access in Children: A Systematic Review and Subgroup Meta-Analysis. Hu Li Za Zhi. 2017;64:69–80. doi: 10.6224/JN.000070. [DOI] [PubMed] [Google Scholar]
  • 26.Park JM, Kim MJ, Yim HW, et al. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016;175:1975–88. doi: 10.1007/s00431-016-2796-5. [DOI] [PubMed] [Google Scholar]
  • 27.Al-Saadi SF, Karimi Moonaghi H, AL-Fayyadh S, et al. Effect of near-infrared vein finder technology on success rate of cannulation in obese diabetic patients. Shiraz E-Med J. 2022;23 doi: 10.5812/semj-120908. [DOI] [Google Scholar]
  • 28.Aulagnier J, Hoc C, Mathieu E, et al. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014;21:858–63. doi: 10.1111/acem.12437. [DOI] [PubMed] [Google Scholar]
  • 29.Guillon P, Makhloufi M, Baillie S, et al. Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres. Haemophilia. 2015;21:21–6. doi: 10.1111/hae.12513. [DOI] [PubMed] [Google Scholar]
  • 30.Drugeon B, Schults JA, Ray-Barruel G, et al. Infrared Devices Versus Traditional Palpation Approach for Peripheral Intravenous Catheter Insertion in Adults: A Systematic Review and Meta-Analysis. J Adv Nurs. 2026;82:1775–90. doi: 10.1111/jan.17007. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 31.Tran QK, Flanagan K, Fairchild M, et al. Nurses and Efficacy of Ultrasound-Guided Versus Traditional Venous Access: A Systemic Review and Meta-Analysis. J Emerg Nurs. 2022;48:145–58. doi: 10.1016/j.jen.2021.12.003. [DOI] [PubMed] [Google Scholar]
  • 32.Xiong X, Xiong Y, Liu G. Systematic review and meta-analysis: safety of ultrasound-guided peripheral venipuncture and catheterization. Ann Palliat Med. 2021;10:11721–32. doi: 10.21037/apm-21-3163. [DOI] [PubMed] [Google Scholar]
  • 33.Rodríguez-Herrera Á, Solaz-García Á, Mollá-Olmos E, et al. Use of the Ultrasound Technique as Compared to the Standard Technique for the Improvement of Venous Cannulation in Patients with Difficult Access. Healthcare (Basel) 2022;10:261. doi: 10.3390/healthcare10020261. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 34.Poulsen E, Aagaard R, Bisgaard J, et al. The effects of ultrasound guidance on first-attempt success for difficult peripheral intravenous catheterization: a systematic review and meta-analysis. Eur J Emerg Med. 2023;30:70–7. doi: 10.1097/MEJ.0000000000000993. [DOI] [PubMed] [Google Scholar]
  • 35.Álvarez-Morales L, Gómez-Urquiza JL, Suleiman-Martos N, et al. Ultrasound-guided peripheral intravenous canulation by emergency nurses: A systematic review and meta-analysis. Int Emerg Nurs. 2024;73:101422. doi: 10.1016/j.ienj.2024.101422. [DOI] [PubMed] [Google Scholar]
  • 36.Loon FHV, Scholten HJ, Korsten HH, et al. The learning curve for ultrasound-guided peripheral intravenous cannulation in adults: a multicenter study. Med Ultrason. 2022;24:188–95. doi: 10.11152/mu-3322. [DOI] [PubMed] [Google Scholar]
  • 37.Yalçınlı S, Karbek Akarca F, Can Ö, et al. Comparison of Standard Technique, Ultrasonography, and Near-Infrared Light in Difficult Peripheral Vascular Access: A Randomized Controlled Trial. Prehosp Disaster Med . 2022;37:65–70. doi: 10.1017/S1049023X21001217. [DOI] [PubMed] [Google Scholar]
  • 38.Chan A-W, Boutron I, Hopewell S, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025;389:e081477. doi: 10.1136/bmj-2024-081477. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 39.Haute Autorité de Santé Prévention des infections liées aux cathéters veineux périphériques - Argumentaire. 2005.
  • 40.Nickel B, Gorski L, Kleidon T, et al. Infusion Therapy Standards of Practice, 9th Edition. Journal of Infusion Nursing. 2024;47:S1–285. doi: 10.1097/NAN.0000000000000532. [DOI] [PubMed] [Google Scholar]
  • 41.Presley B, Isenberg JD. StatPearls. Treasure Island (FL): StatPearls; 2022. Ultrasound guided intravenous access. [Google Scholar]
  • 42.Granry J-C, Moll M-C. Simulation en santé - Haute Autorité de Santé. 2012.
  • 43.Fergusson D, Aaron SD, Guyatt G, et al. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325:652–4. doi: 10.1136/bmj.325.7365.652. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 44.de Boer MR, Waterlander WE, Kuijper LDJ, et al. Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate. Int J Behav Nutr Phys Act. 2015;12:4. doi: 10.1186/s12966-015-0162-z. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 45.Hwang EJ, Shin C-I, Choi YH, et al. Frequency, outcome, and risk factors of contrast media extravasation in 142,651 intravenous contrast-enhanced CT scans. Eur Radiol. 2018;28:5368–75. doi: 10.1007/s00330-018-5507-y. [DOI] [PubMed] [Google Scholar]
  • 46.Wang L, Chen Q, Liu H, et al. Incidence, outcome, and risk factors of contrast media extravasation injury during contrast-enhanced computed tomography scans: an observational cohort study. Quant Imaging Med Surg. 2025;15:7338–51. doi: 10.21037/qims-24-2332. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47.Matsumoto Y, Chikasue A, Kondo M, et al. Feasibility of preventing massive contrast media extravasation using a sensor device in contrast-enhanced CT: an observational study. Acta Radiol. 2024;65:1325–31. doi: 10.1177/02841851241287314. [DOI] [PubMed] [Google Scholar]
  • 48.Kobayashi N, Nakaura T, Shiraishi K, et al. A Novel Approach to Detecting Contrast Extravasation in Computed Tomography: Evaluating the Injection Pressure-to-Injection Rate Ratio. J Comput Assist Tomogr. 2025;49:125–32. doi: 10.1097/RCT.0000000000001614. [DOI] [PubMed] [Google Scholar]
  • 49.Toulouse E, Lafont B, Granier S, et al. French legal approach to patient consent in clinical research. Anaesth Crit Care Pain Med. 2020;39:883–5. doi: 10.1016/j.accpm.2020.10.012. [DOI] [PubMed] [Google Scholar]

Articles from BMJ Open are provided here courtesy of BMJ Publishing Group

RESOURCES