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

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ClinicalTrials.gov Identifier: NCT01793363
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Tracheotomy Procedure: Tracheotomy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: tracheotomized patients Procedure: Tracheotomy



Primary Outcome Measures :
  1. Variation of lung ultrasound score [ Time Frame: at day 1 ]

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


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

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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01793363     History of Changes
Other Study ID Numbers: CHU-0144
2012-A00366-37
First Posted: February 15, 2013    Key Record Dates
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