Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation (ECHODIA)

March 21, 2018 updated by: University Hospital, Strasbourg, France

Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).

Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.

The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

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
      • Strasbourg, France, 67091
        • Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

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

Sampling Method

Non-Probability Sample

Study Population

Critical care patients (surgical or medical)

Description

Inclusion Criteria:

  • Patient extubated after at least 48 hours of invasive ventilation
  • Requiring non invasive ventilation
  • Consent of patient

Exclusion Criteria:

  • Diaphragmatic paralysis
  • Neuromuscular disease
  • significant pleural effusion
  • atelectasis requiring bronchoscopy
  • abdominal hypertension

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diaphragmatic excursion
Time Frame: Before the first NIV session
Before the first NIV session
Diaphragmatic thickening
Time Frame: Before the first NIV session
Before the first NIV session
Diaphragmatic excursion
Time Frame: After the first NIV session
After the first NIV session
Diaphragmatic thickening
Time Frame: After the first NIV session
After the first NIV session
Diaphragmatic excursion
Time Frame: After 24 h of NIV use
After 24 h of NIV use
Diaphragmatic thickening
Time Frame: After 24 h of NIV use
After 24 h of NIV use

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Gharib AJOB, MD, Hôpitaux Universitaires de Strasbourg

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 (ACTUAL)

June 19, 2015

Primary Completion (ACTUAL)

July 15, 2016

Study Completion (ACTUAL)

July 15, 2016

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (ESTIMATE)

March 5, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5957

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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