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

July 23, 2015 updated by: University Hospital, Clermont-Ferrand
Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients tracheotomised during ICU stay
  • Consent of patients

Exclusion Criteria:

  • Tracheotomy before ICU
  • No echogenicity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tracheotomized patients
Procedure: Tracheotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of lung ultrasound score
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to weaning from mechanical ventilation
Time Frame: at day 1
at day 1
Length of hospital stay
Time Frame: Day 1 + 90 days
Day 1 + 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Groupe Hospitalier Pitie-Salpetriere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0144
  • 2012-A00366-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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