Difficult Venous AccessNCT07867132
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
A study testing Near-Infrared Vein Visualization Device and Conventional Vein Localization in people with Difficult Venous Access, run by Raquel López Nieto.
Trial summary
The goal of this clinical trial is to learn whether near-infrared (NIR) light can help healthcare professionals place a peripheral intravenous catheter in adults with difficult venous access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Venous Access
- What is being tested?
- Near-Infrared Vein Visualization Device and Conventional Vein Localization
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to 31 Oct 2027
- 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
- Adults aged 18 years or older who require intravenous treatment expected to last less than one week and that can be administered through a short peripheral intravenous catheter (PIVC) to be inserted in a participating hospital unit.
- A score of 4 or higher on the A-DIVA scale.
- Written informed consent to participate in the study
Who cannot join
- Patients with an existing peripherally inserted central catheter (PICC), centrally inserted central catheter (CICC), femorally inserted central catheter (FICC), implanted vascular access device (PICC-Port or intravenous port), or tunneled vascular access device.
- Patients requiring intravenous treatment that is not appropriate for administration through a short PIVC according to the RNAO vascular access guideline, including solutions with pH <5 or >9, osmolarity >500 mOsm/L, vesicant medications, vasoactive drugs, or parenteral nutrition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Near-Infrared Light in Peripheral Venous Catheterization in Adult Patients With Difficult Venous Access
The goal of this clinical trial is to learn whether near-infrared (NIR) light can help healthcare professionals place a peripheral intravenous catheter in adults with difficult venous access.
The main question it aims to answer is:
Read more
- Does using NIR light make successful catheter placement on the first needle puncture more likely than the usual method of looking for and feeling the vein? Researchers will compare NIR light with the usual method of looking for and feeling the vein to see which method works better for placing the catheter on the first needle puncture.
Participants will:
- Have their veins located using either NIR light or the usual method of looking for and feeling the vein.
- Have a peripheral intravenous catheter placed by a healthcare professional.
- Report their pain and satisfaction with the procedure. Researchers will also record how many needle punctures are needed, how long catheter placement takes, how long the catheter remains in place, why it is removed, and whether any complications occur.
- Conditions
- Difficult Venous Access
- Being tested
- Near-Infrared Vein Visualization Device, Conventional Vein Localization
- Keywords
- Peripheral Intravenous Catheterization, Near-Infrared Light, Vein Visualization, Difficult Venous Access, Peripheral Intravenous Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Vein Visualization DeviceDevice
A near-infrared vein visualization device will be used to locate superficial veins for peripheral intravenous catheter insertion. The device uses near-infrared light to visualize the venous pattern and projects the resulting vein image onto the participant's skin in real time. The device will be used for vein localization before venipuncture and may remain in use during venipuncture and catheter insertion at the healthcare professional's discretion. Peripheral intravenous catheter insertion will otherwise follow the standard procedure.
Conventional Vein LocalizationProcedure or surgery
ein localization will be performed using the conventional method of direct visualization and palpation of the vein, without the use of near-infrared or other vein visualization technology. Peripheral intravenous catheter insertion will then be performed according to the standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| Near-Infrared Light | Experimental | Participants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using near-infrared light. Catheter insertion will otherwise follow the standard procedure. Receives: Device: Near-Infrared Vein Visualization Device |
| Conventional Vein Localization | Active comparator | Participants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using direct visualization and palpation of the vein, without technological assistance. Catheter insertion will otherwise follow the standard procedure. Receives: Procedure: Conventional Vein Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Peripheral Intravenous Catheterization on the First Venipuncture Attempt
Successful catheterization will be defined as venous blood return upon vein entry, advancement of the peripheral intravenous catheter without resistance, and, after tourniquet release, administration of 5-10 mL of saline or initiation of intravenous infusion without resistance, infiltration, or pain. Blood return after final catheter positioning will not be required. The outcome will be recorded as successful or unsuccessful on the first venipuncture attempt.
Measured: During the peripheral intravenous catheter insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Venous AccessStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raquel López Nieto
- Sponsor type
- University, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon
- Responsible party
- Sponsor-investigator, Raquel López Nieto, Sanidad de Castilla y León
- Investigators
- Raquel López Nieto, Principal investigator, Complejo Asistencial de Zamora.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867132
- Sponsor's protocol ID
- 660
- Other IDs
- GRS/3204/A2/2025
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the informed consent and data protection plan approved for this study do not provide for sharing individual participant data beyond the research team and other legally authorized access. Study results will be disseminated in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Near-Infrared Light in Peripheral Venous Catheterization in Adult Patients With Difficult Venous Access
- ClinicalTrials.gov ID
- NCT07867132
- Acronym / sponsor ID
- 660
- Conditions
- Difficult Venous Access
- Keywords
- Peripheral Intravenous Catheterization, Near-Infrared Light, Vein Visualization, Difficult Venous Access, Peripheral Intravenous Catheter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Raquel López NietoUniversity, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Oct 2026 (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 goal of this clinical trial is to learn whether near-infrared (NIR) light can help healthcare professionals place a peripheral intravenous catheter in adults with difficult venous access.
The main question it aims to answer is:
- Does using NIR light make successful catheter placement on the first needle puncture more likely than the usual method of looking for and feeling the vein? Researchers will compare NIR light with the usual method of looking for and feeling the vein to see which method works better for placing the catheter on the first needle puncture.
Participants will:
- Have their veins located using either NIR light or the usual method of looking for and feeling the vein.
- Have a peripheral intravenous catheter placed by a healthcare professional.
- Report their pain and satisfaction with the procedure. Researchers will also record how many needle punctures are needed, how long catheter placement takes, how long the catheter remains in place, why it is removed, and whether any complications occur.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near-Infrared Light | Experimental | Device: Near-Infrared Vein Visualization DeviceParticipants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using near-infrared light. Catheter insertion will otherwise follow the standard procedure. |
| Conventional Vein Localization | Active comparator | Procedure: Conventional Vein LocalizationParticipants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using direct visualization and palpation of the vein, without technological assistance. Catheter insertion will otherwise follow the standard procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older who require intravenous treatment expected to last less than one week and that can be administered through a short peripheral intravenous catheter (PIVC) to be inserted in a participating hospital unit.
- A score of 4 or higher on the A-DIVA scale.
- Written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Patients with an existing peripherally inserted central catheter (PICC), centrally inserted central catheter (CICC), femorally inserted central catheter (FICC), implanted vascular access device (PICC-Port or intravenous port), or tunneled vascular access device.
- Patients requiring intravenous treatment that is not appropriate for administration through a short PIVC according to the RNAO vascular access guideline, including solutions with pH <5 or >9, osmolarity >500 mOsm/L, vesicant medications, vasoactive drugs, or parenteral nutrition.
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 Vein Visualization DeviceA near-infrared vein visualization device will be used to locate superficial veins for peripheral intravenous catheter insertion. The device uses near-infrared light to visualize the venous pattern and projects the resulting vein image onto the participant's skin in real time. The device will be used for vein localization before venipuncture and may remain in use during venipuncture and catheter insertion at the healthcare professional's discretion. Peripheral intravenous catheter insertion will otherwise follow the standard procedure. | Device | Near-Infrared Light |
| Conventional Vein Localizationein localization will be performed using the conventional method of direct visualization and palpation of the vein, without the use of near-infrared or other vein visualization technology. Peripheral intravenous catheter insertion will then be performed according to the standard procedure. | Procedure or surgery | Conventional Vein Localization |
Primary outcome
Successful Peripheral Intravenous Catheterization on the First Venipuncture Attempt
Time frame: During the peripheral intravenous catheter insertion procedure
Successful catheterization will be defined as venous blood return upon vein entry, advancement of the peripheral intravenous catheter without resistance, and, after tourniquet release, administration of 5-10 mL of saline or initiation of intravenous infusion without resistance, infiltration, or pain. Blood return after final catheter positioning will not be required. The outcome will be recorded as successful or unsuccessful on the first venipuncture attempt.
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 9 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the informed consent and data protection plan approved for this study do not provide for sharing individual participant data beyond the research team and other legally authorized access. Study results will be disseminated in aggregate form.
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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.
Raquel López Nieto principal investigator
Complejo Asistencial de Zamora.
Questions about this trial
What is this clinical trial studying?
A study testing Near-Infrared Vein Visualization Device and Conventional Vein Localization in people with Difficult Venous Access, run by Raquel López Nieto.
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 3 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Raquel López Nieto (+34 980 548 200 ext. 48871, rlopezni@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Peripheral Intravenous Catheterization on the First Venipuncture Attempt (time frame: During the peripheral intravenous catheter insertion procedure). 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 9 Oct 2026.