- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138903
A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial (CARWEAN)
November 28, 2014 updated by: University Hospital, Clermont-Ferrand
Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.
Study Type
Observational
Enrollment (Actual)
120
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
-
-
-
Clermont-Ferrand, France, 63003
- CHU de 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
ICU patients
Description
Inclusion Criteria:
Adult patients ventilated requiring first weaning trial of mechanical ventilation
- Stable respiratory and hemodynamic conditions
- Consent of patients or family
- Arterial line
- Ventilated patients
Exclusion Criteria:
-
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 |
Intervention / Treatment |
|---|---|
|
ZEEP and tubing-spontaneous ventilation
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.
|
|
|
trans-thoracic echocardiography
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
left ventricular filling pressure
Time Frame: after 1 hour
|
Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed
|
after 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of other echocardiographic parameters of left ventricular filling pressures
Time Frame: after 1 hour
|
Comparison of other echocardiographic parameters of left ventricular filling pressures (E, Ea, deceleration time) at the end of weaning trial
|
after 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
April 11, 2014
First Submitted That Met QC Criteria
May 13, 2014
First Posted (Estimate)
May 15, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 28, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CHU-189
- 2013-000960-26
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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