NCT01888094

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

June 25, 2013

Last Update Submit

June 24, 2016

Conditions

Requiring Subclavian Vein CannulationAdult PatientsPatient Covered by French Health Care System

Keywords

Central venous catheterComplicationsUltrasoundSubclavian vein cannulationCritical careEchocardiographyChest radiographyiography

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • procedure time Tn-Tn (n 0-5) between the two strategies.

    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

    at day 1

  • failure of technology between the two strategies.

    at day 1

  • occurrence of central venous catheter infection.

    at day 1

Study Arms (2)

ultrasound guided for cannulation and examination

EXPERIMENTAL

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

Other: Ultrasound-guided cannulation and examination

landmark method and examination with chest radiography

OTHER

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

Other: Ultrasound-guided cannulation and examination

Interventions

Ultrasound-guided cannulation and examinationOTHER
landmark method and examination with chest radiographyultrasound guided for cannulation and examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults patients
  • requiring subclavian vein cannulation
  • patient covered by french health care system

You may not qualify if:

  • patient refusal
  • requiring vein cannulation femoral or jugular
  • we see nothing with echocardiography
  • children and not adult patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Perbet S, Pereira B, Grimaldi F, Duale 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.

    PMID: 24885789DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)