Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation (PULCO)

July 4, 2014 updated by: University Hospital, Clermont-Ferrand
Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis.

Study Overview

Status

Completed

Conditions

Detailed Description

Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers

Study Type

Observational

Enrollment (Actual)

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

  • 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

Sampling Method

Non-Probability Sample

Study Population

Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers

Description

Inclusion Criteria:

- Adult patients ventilated more than 48 h

  • Stable respiratory and hemodynamic conditions for SBT
  • Consent of patients
  • Arterial line

Exclusion Criteria:

  • Laryngeal dyspnea
  • Tracheostomy
  • Arythmya
  • No echogenicity
  • Paraplegia >T8

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

Cohorts and Interventions

Group / Cohort
patients requiring ventilation
patients who weaned permanently

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
Time Frame: before, at the end, and 4-6 h after
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
before, at the end, and 4-6 h after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
Time Frame: in the 4-6 early hours
Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
in the 4-6 early hours
Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
Time Frame: in the 4-6 early hours.
Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
in the 4-6 early hours.
Compare the variations of lung ultrasound score during the test of the weaning from mechanical ventilation between patients failed the spontaneous breathing test (SBT) and those extubated after successful SBT.
Time Frame: in the 4-6 early hours
Compare the variations of lung ultrasound score during the test of the weaning from mechanical ventilation between patients failed the spontaneous breathing test (SBT) and those extubated after successful SBT.
in the 4-6 early hours
Comparison of levels epithelial and endothelial markers
Time Frame: at h0, h1, h4, h6
at h0, h1, h4, h6
Constitution serum bank for epithelial (sRAGE) markers dosages
Time Frame: at h0, h1, h4, h6
at h0, h1, h4, h6
constitution serum bank for endothelial (angiopoietin) markers dosages
Time Frame: at h0, h1, h4, h6
at h0, h1, h4, h6

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

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

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 2, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0069
  • 2009-A01310-57 (Other Identifier: Afssaps)

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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