Arterial PunctureNCT07765199
Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension
A study testing Arterial blood gas, Simulated hypotension and Arterial Puncture using Blood'Up device in people with Arterial Puncture and Radial Artery Injury, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Arterial puncture is a common procedure in the management of hospitalized patients. It is most often performed at the level of the radial artery and allows arterial blood gas analysis. The success rate of arterial puncture varies widely in the literature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arterial Puncture, Radial Artery Injury, Hypotension
- What is being tested?
- Arterial blood gas, Simulated hypotension and Arterial Puncture using Blood'Up device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant who has agreed to take part in the study
- No history of cardiovascular disease and a positive Allen test (the Allen test confirms the presence of collateral circulation between the radial and ulnar arteries)
- Age ≥ 18 years
- Body mass index (BMI) < 30 kg/m²
Who cannot join
- Raynaud's syndrome/disease
- Damaged or injured skin at the puncture site or at the Blood'Up device contact area
- Upper limb amputation
- Contraindication to arterial puncture in one or both upper limbs (e.g., skin lesion, lymph node dissection, etc.)
- Contraindication to extrinsic arterial compression
- Therapeutic anticoagulation
Show all 9Show fewer
- Known allergy to thermoplastic (ABS)
- Known allergy to EMLA patch (lidocaine or prilocaine)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Arterial puncture is a common procedure in the management of hospitalized patients. It is most often performed at the level of the radial artery and allows arterial blood gas analysis.
The success rate of arterial puncture varies widely in the literature. This procedure is moderately painful and may cause significant discomfort, particularly in cases of repeated attempts. First-attempt success is therefore important to reduce both pain and the risk of local complications associated with multiple punctures.
Read more
In routine practice, arterial puncture is performed using manual palpation of the radial artery, typically by a trained nurse. In case of failure, a physician may attempt the procedure, often using ultrasound guidance. However, ultrasound is not routinely used and requires specific training and organizational protocols for nurse use.
In hypotensive conditions, such as shock, the radial pulse may become difficult to palpate, making arterial puncture more challenging when using conventional techniques.
The Blood'up device (Arterya, Hérouville, France) is a non-invasive device currently under development that assists in arterial localization. It is applied to the wrist and projects a light signal indicating the position of the artery. This localization is based on ultrasound technology using piezoelectric sensors integrated into the device.
The aim of this study is to evaluate the effectiveness of the Blood'up device for radial artery localization in healthy volunteers, both under physiological conditions (normal blood pressure) and under simulated hypotensive conditions.
- Conditions
- Arterial Puncture, Radial Artery Injury, Hypotension, Healthy
- Being tested
- Arterial blood gas, Simulated hypotension, Arterial Puncture using Blood'Up device
- Keywords
- Arterial Puncture, Blood'Up device, hypotension, healthy volunteers, blood gas analysis
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gasOther
Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
Simulated hypotensionOther
Only for the second cohort with simulated hypotension, which will include 16 healthy volunteers:
Hypotension will be simulated by extrinsic compression using a blood pressure cuff adapted to the volunteer's arm circumference. The (manual) blood pressure cuff will be inflated and maintained to achieve a mean arterial pressure of 60 mmHg (with hypotension defined as a mean arterial pressure below 65 mmHg). Blood pressure will be measured using a non-invasive hemodynamic monitoring device (ClearSight®, Edwards Lifesciences, Mississauga, Canada).
Arterial Puncture using Blood'Up deviceDevice
Blood'Up will be used to detect the radial artery beneath the skin.
| Study group | Role | What they receive |
|---|---|---|
| Arterial puncture using manual palpation | Active comparator | The traditional method for performing radial arterial puncture by manual palpation is as follows:
* Identification of the radial artery pulsation by palpation by the nurse
* Puncture performed at the location where the pulse amplitude is perceived as strongest. Receives: Other: Arterial blood gas; Other: Simulated hypotension |
| Arterial puncture using Blood'Up device | Experimental | Blood'Up is a portable, reusable, non-sterile Class I medical device that uses ultrasound to detect the radial artery beneath the skin. It projects two puncture points connected by a line onto the skin surface directly above the artery. Unlike ultrasound-guided or palpation-based techniques, the device allows the healthcare professional to keep both hands free, enabling the puncture to be performed under optimal conditions. Receives: Other: Arterial blood gas; Other: Simulated hypotension; Device: Arterial Puncture using Blood'Up device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
Success is defined as successful puncture of the radial artery with confirmation of the arterial nature of the sample by blood gas analysis. Only one puncture (defined as a single skin puncture) will be performed on each wrist.
If the needle is withdrawn without obtaining blood return, this will be considered a failed arterial puncture. Similarly, the absence of blood return within one minute after skin puncture will also be considered a failure.
Measured: 5 minutes
Secondary outcomes (4)
Procedure time: from device placement to blood return in the syringe when using the Blood'Up device; and from the start of palpation to blood return in the syringe for manual palpation.
Procedure time is defined as the time from the start of device placement to the onset of blood return in the arterial syringe (expected volume: 1 mL).
For the Blood'Up device, the start is defined as the moment the device is placed on the volunteer's skin.
For manual palpation, the start of palpation defines the start of the procedure.
In both cases (Blood'Up and manual palpation), the maximum allowed procedure time is 1 minute. Similarly, the absence of blood return within one minute after skin puncture will be considered a failure.
Measured: 30 minutes
Pain with and without the Blood'Up device
Pain will be assessed immediately after each puncture by asking the participant to rate the maximum pain experienced during the procedure using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 30 minutes
Number of needle redirections with and without the Blood'Up device.
Number of needle redirections during each puncture, defined as any change in needle angulation (self-reported by the nurse performing the procedure). A puncture is defined as a single skin breach by the needle; as long as the needle is not completely withdrawn from the skin, all manipulations are considered part of the same puncture, regardless of the number of redirections.
Measured: 30 minutes
Immediate complications with and without the Blood'Up device.
Complications related to arterial puncture occurring within 5 minutes after the procedure: hematoma at the puncture site, suspected nerve injury (paresthesia), or vasovagal response (pallor, sweating, bradycardia, syncope).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arterial PunctureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A first phase under physiological conditions (normal blood pressure): an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. A second phase under simulated hypotensive conditions: an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. Each healthy volunteer will participate in only one of the two conditions, with a maximum of two punctures in total. Each cohort will include 16 volunteers. The study will be randomized according to two criteria: * The order of the tested conditions: manual palpation versus Blood'Up * The side of puncture: left versus right radial artery
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765199
- Sponsor's protocol ID
- CHUO-2025-04
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barthelemy A, Gagnon DH, Duclos C. Gait-like vibration training improves gait abilities: a case report of a 62-year-old person with a chronic incomplete spinal cord injury. Spinal Cord Ser Cases. 2016 Jul 21;2:16012. doi: 10.1038/scsandc.2016.12. eCollection 2016.
PubMed 28053756Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
PubMed 28697708Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.
PubMed 26206167Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
PubMed 31730754Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986 Feb;66(2):206-9. doi: 10.1093/ptj/66.2.206.
PubMed 3945674
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension
- ClinicalTrials.gov ID
- NCT07765199
- Acronym / sponsor ID
- CHUO-2025-04
- Conditions
- Arterial Puncture, Radial Artery Injury, Hypotension, Healthy
- Keywords
- Arterial Puncture, Blood'Up device, hypotension, healthy volunteers, blood gas analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Aug 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.
Arterial puncture is a common procedure in the management of hospitalized patients. It is most often performed at the level of the radial artery and allows arterial blood gas analysis.
The success rate of arterial puncture varies widely in the literature. This procedure is moderately painful and may cause significant discomfort, particularly in cases of repeated attempts. First-attempt success is therefore important to reduce both pain and the risk of local complications associated with multiple punctures.
In routine practice, arterial puncture is performed using manual palpation of the radial artery, typically by a trained nurse. In case of failure, a physician may attempt the procedure, often using ultrasound guidance. However, ultrasound is not routinely used and requires specific training and organizational protocols for nurse use.
In hypotensive conditions, such as shock, the radial pulse may become difficult to palpate, making arterial puncture more challenging when using conventional techniques.
The Blood'up device (Arterya, Hérouville, France) is a non-invasive device currently under development that assists in arterial localization. It is applied to the wrist and projects a light signal indicating the position of the artery. This localization is based on ultrasound technology using piezoelectric sensors integrated into the device.
The aim of this study is to evaluate the effectiveness of the Blood'up device for radial artery localization in healthy volunteers, both under physiological conditions (normal blood pressure) and under simulated hypotensive conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A first phase under physiological conditions (normal blood pressure): an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. A second phase under simulated hypotensive conditions: an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. Each healthy volunteer will participate in only one of the two conditions, with a maximum of two punctures in total. Each cohort will include 16 volunteers. The study will be randomized according to two criteria: * The order of the tested conditions: manual palpation versus Blood'Up * The side of puncture: left versus right radial artery
| Arm | Type | Receives |
|---|---|---|
| Arterial puncture using manual palpation | Active comparator | Other: Arterial blood gas, Other: Simulated hypotensionThe traditional method for performing radial arterial puncture by manual palpation is as follows: * Identification of the radial artery pulsation by palpation by the nurse * Puncture performed at the location where the pulse amplitude is perceived as strongest. |
| Arterial puncture using Blood'Up device | Experimental | Other: Arterial blood gas, Other: Simulated hypotension, Device: Arterial Puncture using Blood'Up deviceBlood'Up is a portable, reusable, non-sterile Class I medical device that uses ultrasound to detect the radial artery beneath the skin. It projects two puncture points connected by a line onto the skin surface directly above the artery. Unlike ultrasound-guided or palpation-based techniques, the device allows the healthcare professional to keep both hands free, enabling the puncture to be performed under optimal conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant who has agreed to take part in the study
- No history of cardiovascular disease and a positive Allen test (the Allen test confirms the presence of collateral circulation between the radial and ulnar arteries)
- Age ≥ 18 years
- Body mass index (BMI) < 30 kg/m²
Key exclusion criteria (9 listed)
- Raynaud's syndrome/disease
- Damaged or injured skin at the puncture site or at the Blood'Up device contact area
- Upper limb amputation
- Contraindication to arterial puncture in one or both upper limbs (e.g., skin lesion, lymph node dissection, etc.)
- Contraindication to extrinsic arterial compression
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 |
|---|---|---|
| Arterial blood gasEach healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device). | Other | Arterial puncture using Blood'Up device, Arterial puncture using manual palpation |
| Simulated hypotensionOnly for the second cohort with simulated hypotension, which will include 16 healthy volunteers: Hypotension will be simulated by extrinsic compression using a blood pressure cuff adapted to the volunteer's arm circumference. The (manual) blood pressure cuff will be inflated and maintained to achieve a mean arterial pressure of 60 mmHg (with hypotension defined as a mean arterial pressure below 65 mmHg). Blood pressure will be measured using a non-invasive hemodynamic monitoring device (ClearSight®, Edwards Lifesciences, Mississauga, Canada). | Other | Arterial puncture using Blood'Up device, Arterial puncture using manual palpation |
| Arterial Puncture using Blood'Up deviceBlood'Up will be used to detect the radial artery beneath the skin. | Device | Arterial puncture using Blood'Up device |
Primary outcome
Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
Time frame: 5 minutes
Success is defined as successful puncture of the radial artery with confirmation of the arterial nature of the sample by blood gas analysis. Only one puncture (defined as a single skin puncture) will be performed on each wrist. If the needle is withdrawn without obtaining blood return, this will be considered a failed arterial puncture. Similarly, the absence of blood return within one minute after skin puncture will also be considered a failure.
4 secondary outcomes
Procedure time: from device placement to blood return in the syringe when using the Blood'Up device; and from the start of palpation to blood return in the syringe for manual palpation.
Time frame: 30 minutes
Pain with and without the Blood'Up device
Time frame: 30 minutes
Number of needle redirections with and without the Blood'Up device.
Time frame: 30 minutes
Immediate complications with and without the Blood'Up device.
Time frame: 30 minutes
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 14 Aug 2026.
- Background: PubMed 28053756Barthelemy A, Gagnon DH, Duclos C. Gait-like vibration training improves gait abilities: a case report of a 62-year-old person with a chronic incomplete spinal cord injury. Spinal Cord Ser Cases. 2016 Jul 21;2:16012. doi: 10.1038/scsandc.2016.12. eCollection 2016.
- Background: PubMed 28697708Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
- Background: PubMed 26206167Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.
- Background: PubMed 31730754Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
- Background: PubMed 3945674Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986 Feb;66(2):206-9. doi: 10.1093/ptj/66.2.206.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial blood gas, Simulated hypotension and Arterial Puncture using Blood'Up device in people with Arterial Puncture and Radial Artery Injury, run by Centre Hospitalier Régional d'Orléans 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 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: opening soon, as of the sponsor's last update on 14 Aug 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 Mai-Anh NAY, MD (0238575253, maianh.nay@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history (time frame: 5 minutes). 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 NCT07765199, which also lists 5 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 14 Aug 2026.