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

Tracheotomy Clinical Trial

— TRAWELUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793363
• Other study ID #: CHU-0144
• Secondary ID: 2012-A00366-37
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: July 23, 2015
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients tracheotomised during ICU stay

• Consent of patients

Exclusion Criteria:

• Tracheotomy before ICU

• No echogenicity

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tracheotomy

Intervention

Procedure:
• Tracheotomy

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of lung ultrasound score		at day 1	No
Secondary	Time to weaning from mechanical ventilation		at day 1	No
Secondary	Length of hospital stay		Day 1 + 90 days	Yes