Respiratory InsufficiencyETCCCVNCT02821429
Respiratory Weaning Following Cardiac Surgery.
An observational study of Respiratory Insufficiency, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Combined Thoracic Echography Record
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited during the pre anesthetic visit
Who may be able to join
- Adult (> 18 years old) beneficiating of mechanical ventilation following cardiac surgery
- Weaning test period
- Patient insured under the French social security system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.
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
- Conditions
- Respiratory Insufficiency
- Being tested
- Combined Thoracic Echography Record
- Keywords
- Respiratory weaning, Pulmonary ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Thoracic Echography RecordOther
This examination will be done to do the longitudinal follow-up of the patient
| Study group | Role | What they receive |
|---|---|---|
| Patient with mechanical ventilation | Patient will be followed with combined Thoracic Echography Record Receives: Other: Combined Thoracic Echography Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation
Measured: 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
Measured: 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
Measured: H0, H1 and H48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MAYEUR, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821429
- Sponsor's protocol ID
- RC31/15/7850
- Acronym
- ETCCCV
- Status last verified
- Jun 2019
- First submitted
- 28 Jun 2016
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.
- ClinicalTrials.gov ID
- NCT02821429
- Acronym / sponsor ID
- ETCCCV / RC31/15/7850
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory weaning, Pulmonary ventilation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with mechanical ventilation | – | Other: Combined Thoracic Echography RecordPatient will be followed with combined Thoracic Echography Record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during the pre anesthetic visit
Key inclusion criteria (3 listed)
- Adult (> 18 years old) beneficiating of mechanical ventilation following cardiac surgery
- Weaning test period
- Patient insured under the French social security system
Key exclusion criteria (7 listed)
- Tracheostomy
- Neurological disorders
- Need for prophylactic non invasive ventilation.
- Global obstructive lung disease with a forced expiratory volume < 50%.
- Judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Thoracic Echography RecordThis examination will be done to do the longitudinal follow-up of the patient | Other | Patient with mechanical ventilation |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas MAYEUR, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.