SUBclavian Central Venous Catheters Guidance and Examination by UltraSound

Adult Patients Clinical Trial

— SUBGEUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888094
• Other study ID #: CHU-0159
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 25, 2013
• Last updated: June 24, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Patients
• Patient Covered by French Health Care System
• Requiring Subclavian Vein Cannulation

Intervention

Other:
• Ultrasound-guided cannulation and examination

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		at day 1	No
Secondary	procedure time Tn-Tn (n 0-5) between the two strategies.		at day 1	No
Secondary	incidence of occurrence of complications: pneumothorax, hemothorax, bad positioning (outside of the superior vena cava or the right atrium) between the two strategies		at day 1	No
Secondary	failure of technology between the two strategies.		at day 1	No
Secondary	occurrence of central venous catheter infection.		at day 1	No