NCT02821429

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

4 years

First QC Date

June 28, 2016

Last Update Submit

June 5, 2019

Conditions

Keywords

Respiratory weaningPulmonary ventilation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation

    1 hour after the weaning test and 48h after

Secondary Outcomes (2)

  • 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

    H0 and 48h after the weaning test

  • Evaluation of diagnostic value of combined Thoracic Echography (ETC) after failure to weaning test as assessed be ECT scores collected

    H0, H1 and H48

Study Arms (1)

Patient with mechanical ventilation

Patient will be followed with combined Thoracic Echography Record

Other: Combined Thoracic Echography Record

Interventions

This examination will be done to do the longitudinal follow-up of the patient

Patient with mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited during the pre anesthetic visit

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Nicolas MAYEUR, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 1, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations