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

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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

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • procedure time Tn-Tn (n 0-5) between the two strategies. [ Time Frame: at day 1 ]
  • 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 ]
  • failure of technology between the two strategies. [ Time Frame: at day 1 ]
  • occurrence of central venous catheter infection. [ Time Frame: at day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SUBclavian Central Venous Catheters Guidance and Examination by UltraSound
Official Title  ICMJE SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method
Brief Summary Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound
Detailed Description One groupe : Ultrasound guided for cannulation and examination of absence ofcomplications One groupe : landmark method and examination with chest radiography
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Requiring Subclavian Vein Cannulation
  • Adult Patients
  • Patient Covered by French Health Care System
Intervention  ICMJE Other: Ultrasound-guided cannulation and examination
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Other: Ultrasound-guided cannulation and examination
Publications * Perbet S, Pereira B, Grimaldi F, Dualé C, Bazin JE, Constantin JM. Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:175. doi: 10.1186/1745-6215-15-175.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888094
Other Study ID Numbers  ICMJE CHU-0159
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP