Peripheral Venous CatheterizationREUSSIR-VVPNCT06838364
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
A study testing Infrared peripheral venous technique, Ultrasound-guided peripheral venous technique and Landmark technique in people with Peripheral Venous Catheterization, run by Poitiers University Hospital at 1 site in France.
Trial summary
Peripheral venous catheterization (PVC) is the most common invasive procedure in healthcare worldwide. Improving the success rate of PVC on the first attempt is crucial for patients, as it impacts pain, anxiety, the risk of extravasation, rapid access to care, and the patient-provider relationship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Venous Catheterization
- What is being tested?
- Infrared peripheral venous technique, Ultrasound-guided peripheral venous technique and Landmark technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2025to 8 Apr 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or over
- Patient with a CT scan appointment and a medical prescription requiring a peripheral venous line.
- Patient with an A-DIVA score greater than or equal to 2.
- Patient able and willing to comply with all study procedures.
- Patient covered by a social security scheme or covered through a third party.
- Patients who have given their free and informed written consent following clear and fair information about the study.
Who cannot join
- Patient with a contraindication to VVP insertion:
- Arm with arteriovenous fistula
- Limb with an orthopaedic or vascular prosthesis
- Previous mastectomy, axillary lymph node dissection or homolateral radiotherapy of the arm
- Paralysed limb
- Presence of haematomas or puncture site wounds
Show all 9Show fewer
- Limb with phlebitis or infection
- Patients already included in the study
- Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, pregnant or breast-feeding women, adults under legal protection and patients in emergency situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Poitiers Hospital
Poitiers, 86000
Guillaume DAVY, 516604285 ext. 33, guillaume.davy@chu-poitiers.fr
About this study
Peripheral venous catheterization (PVC) is the most common invasive procedure in healthcare worldwide. Improving the success rate of PVC on the first attempt is crucial for patients, as it impacts pain, anxiety, the risk of extravasation, rapid access to care, and the patient-provider relationship. For healthcare providers, a higher success rate enhances self-confidence and autonomy, while institutions benefit from improved reputation and reduced costs.
In the Poitiers hosptial, one in ten catheters is used in imaging services, with CT scan departments accounting for 66.3% of catheter usage due to iodinated contrast injections. Literature suggests two techniques to enhance PVC success: ultrasound-guided and infrared illumination methods. These techniques appear effective primarily for patients with difficult venous access. Additionally, the A-DIVA clinical score has been developed to predict first-attempt success rates. However, no studies in Europe have compared the effectiveness of these two techniques in imaging settings or based on the A-DIVA score. This study aims to identify the most effective technique for PVC in patients with difficult venous access.
Read the detailed description
This is a prospective, controlled, randomized, three-arm, single-center, superiority trial involving patients with difficult venous access.
Control group: Classical method based on clinical examination (visualization and palpation).
Experimental1 group: Ultrasound-guided method. Experimental2 group: Infrared illumination method. A total of 249 patients will be enrolled, with 82 patients in each group. The inclusion period will last 12 months, and each participant will be involved for a maximum of 4 hours. The total duration of the clinical investigation will be 1 year and 4 hours.
- Conditions
- Peripheral Venous Catheterization
- Being tested
- Infrared peripheral venous technique, Ultrasound-guided peripheral venous technique, Landmark technique
- Keywords
- ultrasound guided, infrared, A-DIVA scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared peripheral venous techniqueOther
Also called 2
use a infrared device for venous peripheral visualisation and catheter insertion
Ultrasound-guided peripheral venous techniqueOther
Also called 1
Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion
Landmark techniqueOther
Also called control
the gold standard technique with observationnal and palpation
| Study group | Role | What they receive |
|---|---|---|
| Standard technique | Active comparator | The gold standard technique, with observationnal and palpation Receives: Other: Landmark technique |
| Infrared peripheral venous technique | Active comparator | use an infrared device for venous peripheral visualisation and catheter insertion Receives: Other: Infrared peripheral venous technique |
| Ultrasound-guided peripheral venous technique | Active comparator | Use the Ultrasound-guided technique for venous peripheral visualisation and catheter insertion Receives: Other: Ultrasound-guided peripheral venous technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a successful catheterization at the first attempt
Success of the cathetherization is defined by a functional cathether without immediate complication : absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)
Measured: Up to 4 hours
Secondary outcomes (8)
Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt)
Success of the cathetherization is defined by a functional cathether without immediate complication : absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)
Measured: Up to 4 hours
The number of attempts
The number of attempts will be assessed by the number of breach of the skin barrier by a catheter
Measured: Up to 4 hours
The maximum pain felt by the patient during the attempts
Maximum pain will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Measured: Up to 4 hours
Overall satisfaction of the patient
Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Measured: Up to 4 hours
Overall satisfaction of the caregiver
Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Measured: Up to 4 hours
Time-to-catheterisation
Time from the end of material preparation to a successful catheterisation.
Measured: Up to 4 hours
Description of the rescue technique after 2 failures
Rescue system chosen by the carer after 2 failures (call a colleague, continue with the conventional method, ultrasound-guided technique, infrared illumination technique or abandon peripheral venous insertion).
Measured: Up to 4 hours
Catheter size used for the successful catheterisation
Catheter sizes chosen by carers
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start8 Apr 2025
- Primary completion8 Apr 2028 (estimated)
- Study completion8 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a comparative, prospective, controlled, randomized trial with three parallel arms, conducted at a single center, with a superiority design, in patients with difficult venous access.
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838364
- Sponsor's protocol ID
- REUSSIR-VVP
- Acronym
- REUSSIR-VVP
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
- ClinicalTrials.gov ID
- NCT06838364
- Acronym / sponsor ID
- REUSSIR-VVP / REUSSIR-VVP
- Conditions
- Peripheral Venous Catheterization
- Keywords
- ultrasound guided, infrared, A-DIVA scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 8 Apr 2028 (estimated)
- First posted
- 20 Feb 2025 (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.
Peripheral venous catheterization (PVC) is the most common invasive procedure in healthcare worldwide. Improving the success rate of PVC on the first attempt is crucial for patients, as it impacts pain, anxiety, the risk of extravasation, rapid access to care, and the patient-provider relationship. For healthcare providers, a higher success rate enhances self-confidence and autonomy, while institutions benefit from improved reputation and reduced costs.
In the Poitiers hosptial, one in ten catheters is used in imaging services, with CT scan departments accounting for 66.3% of catheter usage due to iodinated contrast injections. Literature suggests two techniques to enhance PVC success: ultrasound-guided and infrared illumination methods. These techniques appear effective primarily for patients with difficult venous access. Additionally, the A-DIVA clinical score has been developed to predict first-attempt success rates. However, no studies in Europe have compared the effectiveness of these two techniques in imaging settings or based on the A-DIVA score. This study aims to identify the most effective technique for PVC in patients with difficult venous access.
Detailed description
This is a prospective, controlled, randomized, three-arm, single-center, superiority trial involving patients with difficult venous access.
Control group: Classical method based on clinical examination (visualization and palpation).
Experimental1 group: Ultrasound-guided method. Experimental2 group: Infrared illumination method. A total of 249 patients will be enrolled, with 82 patients in each group. The inclusion period will last 12 months, and each participant will be involved for a maximum of 4 hours. The total duration of the clinical investigation will be 1 year and 4 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a comparative, prospective, controlled, randomized trial with three parallel arms, conducted at a single center, with a superiority design, in patients with difficult venous access.
| Arm | Type | Receives |
|---|---|---|
| Standard technique | Active comparator | Other: Landmark techniqueThe gold standard technique, with observationnal and palpation |
| Infrared peripheral venous technique | Active comparator | Other: Infrared peripheral venous techniqueuse an infrared device for venous peripheral visualisation and catheter insertion |
| Ultrasound-guided peripheral venous technique | Active comparator | Other: Ultrasound-guided peripheral venous techniqueUse the Ultrasound-guided technique for venous peripheral visualisation and catheter insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 or over
- Patient with a CT scan appointment and a medical prescription requiring a peripheral venous line.
- Patient with an A-DIVA score greater than or equal to 2.
- Patient able and willing to comply with all study procedures.
- Patient covered by a social security scheme or covered through a third party.
Key exclusion criteria (9 listed)
- Patient with a contraindication to VVP insertion:
- Arm with arteriovenous fistula
- Limb with an orthopaedic or vascular prosthesis
- Previous mastectomy, axillary lymph node dissection or homolateral radiotherapy of the arm
- Paralysed limb
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 |
|---|---|---|
| Infrared peripheral venous techniqueAlso: 2use a infrared device for venous peripheral visualisation and catheter insertion | Other | Infrared peripheral venous technique |
| Ultrasound-guided peripheral venous techniqueAlso: 1Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion | Other | Ultrasound-guided peripheral venous technique |
| Landmark techniqueAlso: controlthe gold standard technique with observationnal and palpation | Other | Standard technique |
Primary outcome
The proportion of patients with a successful catheterization at the first attempt
Time frame: Up to 4 hours
Success of the cathetherization is defined by a functional cathether without immediate complication : absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)
8 secondary outcomes
Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt)
Time frame: Up to 4 hours
The number of attempts
Time frame: Up to 4 hours
The maximum pain felt by the patient during the attempts
Time frame: Up to 4 hours
Overall satisfaction of the patient
Time frame: Up to 4 hours
Overall satisfaction of the caregiver
Time frame: Up to 4 hours
Time-to-catheterisation
Time frame: Up to 4 hours
Description of the rescue technique after 2 failures
Time frame: Up to 4 hours
Catheter size used for the successful catheterisation
Time frame: Up to 4 hours
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 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral Venous Catheterization
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
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
Not yet recruiting
Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
Peripheral Intravenous Cannulation, Pain Management
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared peripheral venous technique, Ultrasound-guided peripheral venous technique and Landmark technique in people with Peripheral Venous Catheterization, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 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 1 Sep 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 Guillaume DAVY, Master (+33516604285, guillaume.davy@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a successful catheterization at the first attempt (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.