SUBclavian Central Venous Catheters Guidance and Examination by UltraSound

Phase 2

Completed

• Conditions: Requiring Subclavian Vein Cannulation; Patient Covered by French Health Care System; Adult Patients
• Interventions: Other: Ultrasound-guided cannulation and examination

• Registration Number: NCT01888094
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
landmark method and examination with chest radiography	Ultrasound-guided cannulation and examination	Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound
ultrasound guided for cannulation and examination	Ultrasound-guided cannulation and examination	Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France