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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01400-51 | Other Identifier | ANSM |
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The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subclavian vein access | Experimental |
| |
| Internal jugular vein access | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Central venous catheterization | Procedure | Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful placement catheter from a maximum of two attempts | Binary yes/no | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax | binary yes/no | 1 day |
| arterial puncture | binary yes/no | within 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Roger, MD | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36385459 | Result | Fournil C, Boulet N, Bastide S, Louart B, Ambert A, Boutin C, Lefrant JY, Muller L, Roger C. High success rates of ultrasound-guided distal internal jugular vein and axillary vein approaches for central venous catheterization: A randomized controlled open-label pilot trial. J Clin Ultrasound. 2023 Jan;51(1):158-166. doi: 10.1002/jcu.23383. Epub 2022 Nov 17. |
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| ID | Term |
|---|---|
| D002405 | Catheterization, Central Venous |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| failure | binary yes/no | within 1 hour |
| arrhythmia | binary yes/no | within 1 hour |
| abberant placement of catheter | binary yes/no | 1 day |
| catheter infection | binary yes/no | at removal of catheter; on average 6.5 days |
| catheter colonization | binary yes/no | at removal of catheter; on average 6.5 days |
| mediastinal hematoma | binary yes/no | 1 day |
| thrombosis | binary yes/no | until removal of catheter; on average 6.5 days |
| success at first attempt | yes/no | within 1 hour |
| time between puncture until insertion of guide | measure in seconds | within 1 hour |
| clinical variables associated with failure of the techniques | within 24 hours |
| number of dressings | per day | over length of hospitalization; maximum 40 days |
| nurse-rated satisfaction at each dressing replacement | score 0-10 | over length of hospitalization; maximum 40 days |
| haemothorax | binary yes/no | 1 day |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |