Peripheral Venous CatheterizationICARENCT03932214
Infrared for Peripheral Venous Catheterization in the Critically-ill
A study testing ACCUVEIN in people with Peripheral Venous Catheterization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and… 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?
- ACCUVEIN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2019to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years; Hospitalization in intensive care;
- Need for a peripheral venous catheter;
- Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
- Affiliation to the social security
Who cannot join
- Patient who has already been enrolled in the ICARE study during the current hospitalization;
- Refusal of patient's participation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri-Mondor Hospital
Créteil, Val De Marne, 94000
Fabien Boussely, fabien.boussely@aphp.fr
About this study
Official title: Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients
Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.
Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.
It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.
- Conditions
- Peripheral Venous Catheterization
- Being tested
- ACCUVEIN
- Keywords
- venous access, illumination, infrared, critically-ill, catheterization
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCUVEINDevice
The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.
| Study group | Role | What they receive |
|---|---|---|
| Infrared illumination group | Experimental | The nurse uses the Accuvein® device to identify the veins before puncture. Receives: Device: ACCUVEIN |
| Control group | No intervention | The nurse proceeds as usual (visual identification in the light of the room and palpation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of primary success of peripheral venous catheterization in the upper limbs.
success defined as the need of a single puncture for the effective catheterization.
The effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.
Measured: Day 1
Secondary outcomes (2)
Number of punctures required for peripheral venous catheterization.
Measured: Day 1
Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start19 Dec 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be divided into two groups with a 1: 1 ratio. Each patient will be assigned to one of the following 2 arms: \- Usual technique : Visualization of the vein to be catheterized will be done directly. without infrared illumination. or -Use of the Accuvein® device: Visualization of the vein to be catheterized will be done with infrared illumination. In both groups, catheterization will be carried out according to the usual technique in accordance with the recommendations.
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien BOUSSELY, senior officer, Principal investigator, Assistance publique des hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932214
- Sponsor's protocol ID
- PHRIP-18-0617
- Acronym
- ICARE
- Status last verified
- May 2023
- First submitted
- 26 Apr 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
PubMed 23353941Loon 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 27100437Ouedraogo R, Alves A, Bruant A, Sy O, Tabra Osorio C, Schortgen F, Chenal A, Contou D, Krzyzaniak L, Fartoukh M, Le Joncour M, Mongardon N, Ait Benaissa L, Da Silva D, Bouguerra M, Demeret S, Tanguy Dubois S, Starczala E, Petyt C, Schmidt M, Dezellus S, Georger JF, Pallud AC, Carras D, Boussely F, Audureau E, Mekontso Dessap A. Infrared illumination for difficult peripheral venous catheterisation in critically ill adult patients: the prospective, randomised, multicentre ICARE trial. BMJ Open. 2025 Feb 6;15(2):e090611. doi: 10.1136/bmjopen-2024-090611.
PubMed 39915026
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients
- ClinicalTrials.gov ID
- NCT03932214
- Acronym / sponsor ID
- ICARE / PHRIP-18-0617
- Conditions
- Peripheral Venous Catheterization
- Keywords
- venous access, illumination, infrared, critically-ill, catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 30 Apr 2019 (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 is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.
Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.
It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be divided into two groups with a 1: 1 ratio. Each patient will be assigned to one of the following 2 arms: - Usual technique : Visualization of the vein to be catheterized will be done directly. without infrared illumination. or -Use of the Accuvein® device: Visualization of the vein to be catheterized will be done with infrared illumination. In both groups, catheterization will be carried out according to the usual technique in accordance with the recommendations.
| Arm | Type | Receives |
|---|---|---|
| Infrared illumination group | Experimental | Device: ACCUVEINThe nurse uses the Accuvein® device to identify the veins before puncture. |
| Control group | No intervention | –The nurse proceeds as usual (visual identification in the light of the room and palpation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years; Hospitalization in intensive care;
- Need for a peripheral venous catheter;
- Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
- Affiliation to the social security
Key exclusion criteria (2 listed)
- Patient who has already been enrolled in the ICARE study during the current hospitalization;
- Refusal of patient's participation
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 |
|---|---|---|
| ACCUVEINThe nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device. | Device | Infrared illumination group |
Primary outcome
Percentage of primary success of peripheral venous catheterization in the upper limbs.
Time frame: Day 1
success defined as the need of a single puncture for the effective catheterization. The effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.
2 secondary outcomes
Number of punctures required for peripheral venous catheterization.
Time frame: Day 1
Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 23353941Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
- Background: PubMed 27100437Loon 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.
- Derived from this study: PubMed 39915026Ouedraogo R, Alves A, Bruant A, Sy O, Tabra Osorio C, Schortgen F, Chenal A, Contou D, Krzyzaniak L, Fartoukh M, Le Joncour M, Mongardon N, Ait Benaissa L, Da Silva D, Bouguerra M, Demeret S, Tanguy Dubois S, Starczala E, Petyt C, Schmidt M, Dezellus S, Georger JF, Pallud AC, Carras D, Boussely F, Audureau E, Mekontso Dessap A. Infrared illumination for difficult peripheral venous catheterisation in critically ill adult patients: the prospective, randomised, multicentre ICARE trial. BMJ Open. 2025 Feb 6;15(2):e090611. doi: 10.1136/bmjopen-2024-090611.
- Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically Guided Peripheral Intravenous Cannulation of Children and Adults: A Systematic Review and Meta-analysis - ScienceDirect \[Internet\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien BOUSSELY, senior officer principal investigator
Assistance publique des hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCUVEIN in people with Peripheral Venous Catheterization, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien BOUSSELY, senior officer (01 49 81 42 50 ext. 33, fabien.boussely@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of primary success of peripheral venous catheterization in the upper limbs. (time frame: Day 1). 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 NCT03932214, which also lists 3 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 15 May 2023.