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SUBclavian Central Venous Catheters Guidance and Examination by UltraSound (SUBGEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01888094
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

Condition or disease Intervention/treatment Phase
Requiring Subclavian Vein Cannulation Adult Patients Patient Covered by French Health Care System Other: Ultrasound-guided cannulation and examination Phase 2 Phase 3

Detailed Description:
One groupe : Ultrasound guided for cannulation and examination of absence ofcomplications One groupe : landmark method and examination with chest radiography

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ultrasound guided for cannulation and examination
Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound
Other: Ultrasound-guided cannulation and examination
landmark method and examination with chest radiography
Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound
Other: Ultrasound-guided cannulation and examination



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. procedure time Tn-Tn (n 0-5) between the two strategies. [ Time Frame: at day 1 ]
  2. 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 ]
  3. failure of technology between the two strategies. [ Time Frame: at day 1 ]
  4. occurrence of central venous catheter infection. [ Time Frame: at day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888094


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01888094     History of Changes
Other Study ID Numbers: CHU-0159
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Central venous catheter
Complications
Ultrasound
Subclavian vein cannulation
Critical care
Echocardiography
Chest radiographyiography