Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score (TRAWELUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01793363
First received: February 7, 2013
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients


Condition Intervention
Tracheotomy
Procedure: Tracheotomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Variation of lung ultrasound score [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to weaning from mechanical ventilation [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Day 1 + 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tracheotomized patients Procedure: Tracheotomy

Detailed Description:

Prospective multicentric study on ICU evaluating Lung Ultrasound Score in tracheotomized patients during weaning from mechanical ventilation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients tracheotomised during ICU stay
  • Consent of patients

Exclusion Criteria:

  • Tracheotomy before ICU
  • No echogenicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793363

Contacts
Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04.73.75.11.95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01793363     History of Changes
Other Study ID Numbers: CHU-0144, 2012-A00366-37
Study First Received: February 7, 2013
Last Updated: February 14, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Tracheotomy
Weaning from mechanical ventilation
Lung ultrasound score

ClinicalTrials.gov processed this record on October 21, 2014