[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651787":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arterial puncture using manual palpation","ACTIVE_COMPARATOR","The traditional method for performing radial arterial puncture by manual palpation is as follows:\n\n* Identification of the radial artery pulsation by palpation by the nurse\n* Puncture performed at the location where the pulse amplitude is perceived as strongest.",[13,14],"Other: Arterial blood gas","Other: Simulated hypotension",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[13,14,20],"Device: Arterial Puncture using Blood'Up device",[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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).",[16,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Simulated hypotension","Only for the second cohort with simulated hypotension, which will include 16 healthy volunteers:\n\nHypotension 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).",[16,9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DEVICE","Arterial Puncture using Blood'Up device","Blood'Up will be used to detect the radial artery beneath the skin.",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mai-Anh NAY, MD","CONTACT","0238575253","maianh.nay@chu-orleans.fr",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHU Orléans","Orléans","45067","France","FR",{"type":50,"coordinates":51},"Point",[52,53],1.90407,47.90248,{"lat":53,"lon":52},[56,57],{"name":38,"role":39,"phone":26,"phoneExt":26,"email":26},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"May Anh NAY, MD","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100651787","bloodup-device-versus-manual-palpation-for-arterial-puncture-in-healthy-volunteers-a-pilot-randomized-study-under-normal-and-simulated-hypotension-100651787",false,"NCT07765199","Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension","Inclusion Criteria:\n\n* Participant who has agreed to take part in the study\n* 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)\n* Age ≥ 18 years\n* Body mass index (BMI) \\\u003C 30 kg\u002Fm²\n\nExclusion Criteria:\n\n* Raynaud's syndrome\u002Fdisease\n* Damaged or injured skin at the puncture site or at the Blood'Up device contact area\n* Upper limb amputation\n* Contraindication to arterial puncture in one or both upper limbs (e.g., skin lesion, lymph node dissection, etc.)\n* Contraindication to extrinsic arterial compression\n* Therapeutic anticoagulation\n* Known allergy to thermoplastic (ABS)\n* Known allergy to EMLA patch (lidocaine or prilocaine)\n* Pregnant or breastfeeding women",true,"ALL","18 Years",{"count":72,"type":73},32,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nThe 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.\n\nIn 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.\n\nIn hypotensive conditions, such as shock, the radial pulse may become difficult to palpate, making arterial puncture more challenging when using conventional techniques.\n\nThe 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.\n\nThe 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.",[79,80,81,82],"Arterial Puncture","Radial Artery Injury","Hypotension","Healthy",[79,84,85,86,87],"Blood'Up device","hypotension","healthy volunteers","blood gas analysis","NOT_YET_RECRUITING","2026-08-10",{"date":91,"type":92},"2026-08-14","ACTUAL",{"date":94,"type":73},"2026-09",{"date":96,"type":73},"2027-09",{"name":5,"class":6},1]