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Respiratory Weaning Following Cardiac Surgery. (ETCCCV)

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ClinicalTrials.gov Identifier: NCT02821429
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status.

Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure


Condition or disease Intervention/treatment
Respiratory Insufficiency Other: Combined Thoracic Echography Record

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.
Study Start Date : January 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient with mechanical ventilation
Patient will be followed with combined Thoracic Echography Record
Other: Combined Thoracic Echography Record
This examination will be done to do the longitudinal follow-up of the patient




Primary Outcome Measures :
  1. Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation [ Time Frame: 1 hour after the weaning test and 48h after ]

Secondary Outcome Measures :
  1. Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed T tube Test score difference between patient who succeed or failed the weaning test [ Time Frame: H0 and 48h after the weaning test ]
  2. Evaluation of diagnostic value of combined Thoracic Echography (ETC) after failure to weaning test as assessed be ECT scores collected [ Time Frame: H0, H1 and H48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited during the pre anesthetic visit
Criteria

Inclusion Criteria:

  • Adult (> 18 years old) beneficiating of mechanical ventilation following cardiac surgery
  • Weaning test period
  • Patient insured under the French social security system

Exclusion Criteria:

  • Tracheostomy
  • Neurological disorders
  • Need for prophylactic non invasive ventilation.
  • Global obstructive lung disease with a forced expiratory volume < 50%.
  • Judicial protection
  • Patient already included in a trial still running.
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821429


Contacts
Contact: Nicolas MAYEUR, MD mayeur.n@chu-toulouse.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, France, 31000
Contact: Nicolas MAYEUR, MD       mayeur.n@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Nicolas MAYEUR, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02821429     History of Changes
Other Study ID Numbers: 15-7850
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
Respiratory weaning
Pulmonary ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases