Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension

10. august 2026 opdateret af: Centre Hospitalier Régional d'Orléans

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Orléans, Frankrig, 45067
        • Chu Orleans
        • Kontakt:
          • Mai-Anh NAY, MD
        • Ledende efterforsker:
          • May Anh NAY, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Known allergy to thermoplastic (ABS)
  • Known allergy to EMLA patch (lidocaine or prilocaine)
  • Pregnant or breastfeeding women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arterial puncture using manual palpation

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.
Andet: Arterial blood gas
Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
Andet: Simulated hypotension

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).
Eksperimentel: Arterial puncture using Blood'Up device
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.
Andet: Arterial blood gas
Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
Andet: Simulated hypotension

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).

Enhed: Arterial Puncture using Blood'Up device
Blood'Up will be used to detect the radial artery beneath the skin.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
Tidsramme: 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.
5 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 30 minutes

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.
30 minutes
Pain with and without the Blood'Up device
Tidsramme: 30 minutes
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).
30 minutes
Number of needle redirections with and without the Blood'Up device.
Tidsramme: 30 minutes
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.
30 minutes
Immediate complications with and without the Blood'Up device.
Tidsramme: 30 minutes
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).
30 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Régional d'Orléans

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. august 2026

Først opslået (Faktiske)

14. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUO-2025-04

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner