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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01793363
First Posted: February 15, 2013
Last Update Posted: July 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Time to weaning from mechanical ventilation [ Time Frame: at day 1 ]
  • Length of hospital stay [ Time Frame: Day 1 + 90 days ]

Enrollment: 60
Study Start Date: August 2012
Study Completion Date: November 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793363


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01793363     History of Changes
Other Study ID Numbers: CHU-0144
2012-A00366-37
First Submitted: February 7, 2013
First Posted: February 15, 2013
Last Update Posted: July 24, 2015
Last Verified: July 2015

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