SUBGEUS: SUBclavian Central Venous Catheters Guidance and Examination by UltraSound

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Completed
• CT.gov ID: NCT01888094
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 10

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jun 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

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 [at day 1]

Secondary Outcome Measures

1. procedure time Tn-Tn (n 0-5) between the two strategies. [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 [at day 1]

3. failure of technology between the two strategies. [at day 1]

4. occurrence of central venous catheter infection. [at day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Sébastien PERBET, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT01888094
• Other Study ID Numbers: CHU-0159
• First Posted: Jun 27, 2013
• Last Update Posted: Jun 27, 2016
• Last Verified: Jun 1, 2016

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

Study Results

No Results Posted as of Jun 27, 2016