Cardiac, Pulmonary and Diaphragm Sonography for the Early Diagnosis of the Different Etiologies Underlying Failure of Weaning From Mechanical Ventilation (WEAN US)

August 23, 2017 updated by: Centre Hospitalier Universitaire Dijon

Combined Cardiac, Pulmonary and Diaphragm Sonography for the Evaluation of Failure in Ventilation Weaning

Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation.

The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on post-operative mechanical ventilation following heart or abdominal surgery

Description

Inclusion Criteria:

  • Patients on mechanical ventilation for at least 48 hours
  • Age ≥ 60 years
  • Patients who have undergone abdominal or heart surgery

Exclusion Criteria:

  • Patients with a known neuromuscular disease
  • Patients younger than 60 years
  • Duration of mechanical ventilation <48h
  • Non-surgical patients
  • Patients with severe COPD

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
Echocardiography
Time Frame: At baseline
At baseline
Lung ultrasonography
Time Frame: At baseline
At baseline
Diaphragm ultrasonography
Time Frame: At baseline
At baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • KLEIN 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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