Status:
RECRUITING
Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Ultrasound Guidance
Central Venous Catheterization
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Up to two-thirds of intensive care unit patients require central venous catheterization for which ultrasound-guided placement is now recommended. In this context, the team performed a prospective rand...
Detailed Description
Central venous catheterization is required in up to two-thirds of intensive care unit patients. Ultrasound-guided placement is now recommended over the "blind" technique to decrease the risk of mechan...
Eligibility Criteria
Inclusion
- Any resuscitation patient requiring subclavian venous catheterization.
- Patients or representatives must have given free, informed consent and signed the consent form or patient included in an emergency situation
- Patients must be affiliated to/or beneficiary of a health insurance scheme.
- All patients must be adults (≥18 years of age).
Exclusion
- Moribund patients
- Patients with severe primary or secondary hemostasis disorders (Pq \< 50 G/L or TP \< 30%, or INR \> 2).
- Patients with a PaO2/FiO2 ratio \< 100 mmHg in mechanically ventilated patients (invasive or non-invasive ventilation).
- Patients with a precarious or unstable respiratory status and significant risk of barotrauma
- Patients for whom it is difficult to visualize the subclavian veins bilaterally (left and right) during ultrasound pre-screening
- Patients with a malformation/deformity of the subclavian region (congenital or acquired: history of surgery/cervical trauma)
- Body mass index \< 15 kg/m² ou \> 40 kg/m²
- Local infection at the puncture site
- Thrombosis of the subclavian or axillary vein
- Patients participating in a category 1 defined RIPH involving subclavian central venous line placement.
- Patients under court protection, guardianship or curatorship.
- Pregnant, parturient or breastfeeding women.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06050902
Start Date
January 16 2024
End Date
August 1 2025
Last Update
April 24 2024
Active Locations (1)
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1
CHU de NIMES
Nîmes, France, 30029