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

June 24, 2016 updated by: University Hospital, Clermont-Ferrand

SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
procedure time Tn-Tn (n 0-5) between the two strategies.
Time Frame: at day 1
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
at day 1
failure of technology between the two strategies.
Time Frame: at day 1
at day 1
occurrence of central venous catheter infection.
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

June 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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