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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 July 2016 |
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Main ID: |
NCT01888094 |
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Date of registration:
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25/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SUBclavian Central Venous Catheters Guidance and Examination by UltraSound
SUBGEUS |
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Scientific title:
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SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01888094 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Sébastien PERBET |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adults patients
- requiring subclavian vein cannulation
- patient covered by french health care system
Exclusion Criteria:
- patient refusal
- requiring vein cannulation femoral or jugular
- we see nothing with echocardiography
- children and not adult patients
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult Patients
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Requiring Subclavian Vein Cannulation
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Patient Covered by French Health Care System
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Intervention(s)
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Other: Ultrasound-guided cannulation and examination
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Primary Outcome(s)
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procedure time between the beginning of procedure ( TO) and when the catheter is controlled ( T4) between strategy catheter cannulation 'standard' and a strategy called "ultrasound all
[Time Frame: at day 1]
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Secondary Outcome(s)
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failure of technology between the two strategies.
[Time Frame: at day 1]
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procedure time Tn-Tn (n 0-5) between the two strategies.
[Time Frame: at day 1]
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incidence of occurrence of complications: pneumothorax, hemothorax, bad positioning (outside of the superior vena cava or the right atrium) between the two strategies
[Time Frame: at day 1]
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occurrence of central venous catheter infection.
[Time Frame: at day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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