Upper Limb EdemaNCT06234293
Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit
A study testing near-infrared light device in people with Upper Limb Edema and Critical Illness, run by Centre Hospitalier Régional d'Orléans at 4 sites in France.
Trial summary
The central venous catheter (CVC) is commonly used in intensive care unit (ICU). The primary complications associated with CVCs especially with prolonged use include thrombosis and infections. Hence, it is essential to remove the CVC as soon as it becomes unnecessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Edema, Critical Illness
- What is being tested?
- near-infrared light device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Feb 2024to 16 Jul 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
- ≥18 years old
- Hospitalized in ICU
- with a deep venous catheter (jugular, subclavian or femoral)
- In whom the use of a deep venous line is no longer justified (absence of: vasopressor amines, chemotherapy, parenteral nutrition, hypertonic solutions)
Who cannot join
- Absolute contraindication or anatomical impossibility to perform a PIVC on the upper limbs
- Patient already included in the study
- Tattoo covering most of both forearms
- Adult subject to a legal protection measure (guardianship, curators, person under court protection)
- Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
- Pregnant or breast-feeding woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH de Chartres
Chartres
CH Le Mans
Le Mans
CHU Orléans
Orléans
CHU de Tours
Tours
About this study
Official title: Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study
The central venous catheter (CVC) is commonly used in intensive care unit (ICU). The primary complications associated with CVCs especially with prolonged use include thrombosis and infections. Hence, it is essential to remove the CVC as soon as it becomes unnecessary.
Peripheral intravenous cannulation (PIVC) on a critically ill patient can be a significant challenge for nurses. After several days in ICU, patients may develop significant edema in the upper limbs, complicating the PIVC.
Read more
Near-infrared light devices (NILD) are medical devices that use near-infrared light to highlight the patient's peripheral venous network directly on their skin. The advantage of this device is its minimal training and ease of use for effective application. Nurses can use this medical device without specific conditions once they have received training on its use. The vein illuminator has not been extensively studied in ICU.
This study aims to compare two techniques for PIVC in critically ill patients with existing CVC for whom maintaining the deep venous access is no longer indicated.
The investigators hypothesize that the use of the NILD would increase the success rate of first-attempt PIVC insertion compared to a landmark approach (traditional method) for PIVC in ICU.
Read the detailed description
This is a multicenter randomized controlled study. 380 patients will be randomly assigned with a 1:1 ratio to landmark approach (standard group) or near-infrared light device (interventional group).
Randomization will be done immediately after the enrollment of the patient. Randomization will be stratified by center and according to anticipated difficult venous access defined by:
- BMI > 30 Kg/m2
- Increase in body weight between admission and day of inclusion > 10%.
- Clinically evident edema of the upper limbs (with pitting)
- Absence of visible or palpable veins on arms and forearms If one or more items are present, the patient is classified as difficult to venous access.
Once the patient has been enrolled and randomized, the nurse in charge of the patient performs the PIVC according to the randomization group as soon as possible after randomization.
The nurse will have a maximum of 3 attempts before handing over to another nurse. The total number of attempts will be 5 with the allocated method (traditional method or NILD).
In the case of failure after 5 initial attempts, the intervention will be considered as a failure. However, a maximum of 5 additional attempts will be allowed with any method on the day of randomization. The success or failure of PIVC will be recorded, as well as the device used. The attempts should be performed within 6 hours after randomization.
If one of the 5 first initial attempts is successful, the study continues until the PIVC is removed (max 7 days according to recommendations) or patient discharge, whichever comes first, in order to evaluate the occurrence of local complications.
- Conditions
- Upper Limb Edema, Critical Illness
- Being tested
- near-infrared light device
- Keywords
- Intensive Care Unit, Peripheral Venous Access, Landmark approach, Near-infrared light device, PIVC
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near-infrared light deviceDevice
Nurses will have to find the vein for the PIVC using the near-infrared light device.
| Study group | Role | What they receive |
|---|---|---|
| near-infrared light device | Experimental | the device used is the AccuVein AV500® (Accuvein, New York USA). Nurses will have to find the vein for the PIVC using the near-infrared light device. Nurses will have to proceed as follows: apply the tourniquet, put on the near infrared light onto the upper limb. PIVC on the lower limbs is forbidden in this study. The recommended projection distance is around 20 cm, however, the optimal distance of projection can vary between 10 and 45 cm. After finding the vein, Nurses proceed to PIVC with the device turned on, the peripheral venous network visible on the skin of the patient. After the cannulation and to confirm the functionality of the peripheral intravenous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected Receives: Device: near-infrared light device |
| landmark approach | No intervention | PIVC will be done by a nurse on an upper limb according to the standard approach. The nurse will proceed as follows: apply the tourniquet and find a vein for the catheterization, standard techniques to highlight veins can be used (apply alcohol, tap veins …). After finding a vein, the nurses proceed to the PIVC according to his / her habits. The use of any device is forbidden. After the cannulation and to confirm the functionality of the peripheral venous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate on the first attempt of PIVC in ICU using NILD
To show that the use of the NILD improves the success rate on the first attempt of PIVC in ICU for patients for whom the use of a deep venous catheter is no longer justified.
The success of PIVC will be determined by the presence of venous return during catheterization in the reflux chamber, the full catheter introduction, and the administration of a 10cc syringe of isotonic solution (NaCl 0.9%) with a flash without extravasation. A puncture attempt is defined by the effraction of the skin barrier by the device.
During a puncture, repositioning/change of catheter direction is permitted. Peripheral intravenous puncture will be performed by nurses only.
Measured: Baseline
Secondary outcomes (6)
number of attempts before successful PIVC
Compare the number of attempts before successful PIVC between the traditional method (standard group) and the use of NILD (interventional group).
The number of puncture attempts will be defined by the number of attempts between inclusion and successful of PIVC (last attempt included). On the day of inclusion in the study, each nurse has a maximum of three attempts at PIVC, per patient, depending on the randomization arm. The maximum number of initial attempts per patient is 5.
Measured: Baseline
occurrence of local complications
Compare the occurrence of local complications (phlebitis, extravasation) between the two groups in patients for whom PIVC is considered successful.
- The occurrence and type of local complications within 7 days of successful PIVC will be compared between the two groups, as well as their time of occurrence after placement (until removal of the medical device or until discharge from the hospital department). if the patient is discharged before 7 days).
The main local complications are venous inflammation and extravasation. Local signs to watch out for include pain, swelling and induration. The presence of any of these signs during daily monitoring will lead to its withdrawal. Only medical confirmation of venous inflammation and extravasation will be recorded for this study.
Measured: Day 7
success rate of PIVC according to nurses's experience
Compare the success rate of PIVC according to nurses' experience between the two groups.
The success rate or PIVC according to nurses-experience between the two groups will be compared by stratification: nurses with less than one year's nursing experience, between 1 to 5 years' experience and more than 5 years.
Measured: Baseline
success rate of PIVC in patients considered with anticipated difficult intravenous access
Compare the success rate of PIVC in patients considered with anticipated difficult intravenous access between the two groups.
- Anticipated difficult PIVC will be defined as follows:
- Presence of upper limb edema
- Absence of palpable veins when applying a tourniquet
- Obese patient defined as BMI > 30 kg/m2
- Increase in body weight between admission and day of inclusion > 10%
Measured: Baseline
PIVC insertion time
Compare PIVC insertion time between the two groups
Measured: Baseline
pain levels
Compare pain levels in conscious patients between the two groups using the pain verbal analog scale from 0 to 10, where 0 is no pain and 10 unbearable pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start28 Feb 2024
- Primary completion9 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Upper Limb EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled multicenter trial Ratio 1:1
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aude FERRIER, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234293
- Sponsor's protocol ID
- CHRO-2022-14
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.
PubMed 19836193Carr PJ, Rippey JCR, Cooke ML, Trevenen ML, Higgins NS, Foale AS, Rickard CM. 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 Apr 2;9(4):e022278. doi: 10.1136/bmjopen-2018-022278.
PubMed 30944127Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.
PubMed 29886442Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.
PubMed 25897047Park JM, Kim MJ, Yim HW, Lee WC, Jeong H, Kim NJ. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1975-1988. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.
PubMed 27785562Ferrier A, Despres A, Brasselet A, Badre G, Wanneveich M, Nay MA. Near-infrared light devices versus landmark approach for peripheral venous access in the intensive care unit: protocol of a randomised controlled study. BMJ Open. 2025 Aug 18;15(8):e102390. doi: 10.1136/bmjopen-2025-102390.
PubMed 40829834
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06234293
- Acronym / sponsor ID
- CHRO-2022-14
- Conditions
- Upper Limb Edema, Critical Illness
- Keywords
- Intensive Care Unit, Peripheral Venous Access, Landmark approach, Near-infrared light device, PIVC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 31 Jan 2024 (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.
The central venous catheter (CVC) is commonly used in intensive care unit (ICU). The primary complications associated with CVCs especially with prolonged use include thrombosis and infections. Hence, it is essential to remove the CVC as soon as it becomes unnecessary.
Peripheral intravenous cannulation (PIVC) on a critically ill patient can be a significant challenge for nurses. After several days in ICU, patients may develop significant edema in the upper limbs, complicating the PIVC.
Near-infrared light devices (NILD) are medical devices that use near-infrared light to highlight the patient's peripheral venous network directly on their skin. The advantage of this device is its minimal training and ease of use for effective application. Nurses can use this medical device without specific conditions once they have received training on its use. The vein illuminator has not been extensively studied in ICU.
This study aims to compare two techniques for PIVC in critically ill patients with existing CVC for whom maintaining the deep venous access is no longer indicated.
The investigators hypothesize that the use of the NILD would increase the success rate of first-attempt PIVC insertion compared to a landmark approach (traditional method) for PIVC in ICU.
Detailed description
This is a multicenter randomized controlled study. 380 patients will be randomly assigned with a 1:1 ratio to landmark approach (standard group) or near-infrared light device (interventional group).
Randomization will be done immediately after the enrollment of the patient. Randomization will be stratified by center and according to anticipated difficult venous access defined by:
- BMI > 30 Kg/m2
- Increase in body weight between admission and day of inclusion > 10%.
- Clinically evident edema of the upper limbs (with pitting)
- Absence of visible or palpable veins on arms and forearms If one or more items are present, the patient is classified as difficult to venous access.
Once the patient has been enrolled and randomized, the nurse in charge of the patient performs the PIVC according to the randomization group as soon as possible after randomization.
The nurse will have a maximum of 3 attempts before handing over to another nurse. The total number of attempts will be 5 with the allocated method (traditional method or NILD).
In the case of failure after 5 initial attempts, the intervention will be considered as a failure. However, a maximum of 5 additional attempts will be allowed with any method on the day of randomization. The success or failure of PIVC will be recorded, as well as the device used. The attempts should be performed within 6 hours after randomization.
If one of the 5 first initial attempts is successful, the study continues until the PIVC is removed (max 7 days according to recommendations) or patient discharge, whichever comes first, in order to evaluate the occurrence of local complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled multicenter trial Ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| near-infrared light device | Experimental | Device: near-infrared light devicethe device used is the AccuVein AV500® (Accuvein, New York USA). Nurses will have to find the vein for the PIVC using the near-infrared light device. Nurses will have to proceed as follows: apply the tourniquet, put on the near infrared light onto the upper limb. PIVC on the lower limbs is forbidden in this study. The recommended projection distance is around 20 cm, however, the optimal distance of projection can vary between 10 and 45 cm. After finding the vein, Nurses proceed to PIVC with the device turned on, the peripheral venous network visible on the skin of the patient. After the cannulation and to confirm the functionality of the peripheral intravenous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected |
| landmark approach | No intervention | –PIVC will be done by a nurse on an upper limb according to the standard approach. The nurse will proceed as follows: apply the tourniquet and find a vein for the catheterization, standard techniques to highlight veins can be used (apply alcohol, tap veins …). After finding a vein, the nurses proceed to the PIVC according to his / her habits. The use of any device is forbidden. After the cannulation and to confirm the functionality of the peripheral venous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- Hospitalized in ICU
- with a deep venous catheter (jugular, subclavian or femoral)
- In whom the use of a deep venous line is no longer justified (absence of: vasopressor amines, chemotherapy, parenteral nutrition, hypertonic solutions)
Key exclusion criteria (6 listed)
- Absolute contraindication or anatomical impossibility to perform a PIVC on the upper limbs
- Patient already included in the study
- Tattoo covering most of both forearms
- Adult subject to a legal protection measure (guardianship, curators, person under court protection)
- Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
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 |
|---|---|---|
| near-infrared light deviceNurses will have to find the vein for the PIVC using the near-infrared light device. | Device | near-infrared light device |
Primary outcome
Success rate on the first attempt of PIVC in ICU using NILD
Time frame: Baseline
To show that the use of the NILD improves the success rate on the first attempt of PIVC in ICU for patients for whom the use of a deep venous catheter is no longer justified. The success of PIVC will be determined by the presence of venous return during catheterization in the reflux chamber, the full catheter introduction, and the administration of a 10cc syringe of isotonic solution (NaCl 0.9%) with a flash without extravasation. A puncture attempt is defined by the effraction of the skin barrier by the device. During a puncture, repositioning/change of catheter direction is permitted. Peripheral intravenous puncture will be performed by nurses only.
6 secondary outcomes
number of attempts before successful PIVC
Time frame: Baseline
occurrence of local complications
Time frame: Day 7
success rate of PIVC according to nurses's experience
Time frame: Baseline
success rate of PIVC in patients considered with anticipated difficult intravenous access
Time frame: Baseline
PIVC insertion time
Time frame: Baseline
pain levels
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 19836193Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.
- Background: PubMed 30944127Carr PJ, Rippey JCR, Cooke ML, Trevenen ML, Higgins NS, Foale AS, Rickard CM. 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 Apr 2;9(4):e022278. doi: 10.1136/bmjopen-2018-022278.
- Background: PubMed 29886442Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.
- Background: PubMed 25897047Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.
- Background: PubMed 27785562Park JM, Kim MJ, Yim HW, Lee WC, Jeong H, Kim NJ. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1975-1988. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.
- Derived from this study: PubMed 40829834Ferrier A, Despres A, Brasselet A, Badre G, Wanneveich M, Nay MA. Near-infrared light devices versus landmark approach for peripheral venous access in the intensive care unit: protocol of a randomised controlled study. BMJ Open. 2025 Aug 18;15(8):e102390. doi: 10.1136/bmjopen-2025-102390.
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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.
Aude FERRIER principal investigator
CHU Orléans
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing near-infrared light device in people with Upper Limb Edema and Critical Illness, run by Centre Hospitalier Régional d'Orléans at 4 sites 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 6 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate on the first attempt of PIVC in ICU using NILD (time frame: Baseline). 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 NCT06234293, which also lists 6 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 13 Jan 2026.