Primary Lung Graft DysfunctionETO VD PERIOPNCT02887560
Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.
A study testing transoesophageal echocardiography in people with Primary Lung Graft Dysfunction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Lung Graft Dysfunction
- What is being tested?
- transoesophageal echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2016to 27 Feb 2018
- Phase
- Interventional
- 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
Who may be able to join
- Adult (over 18 years)
- Patient affiliated to a social protection scheme insurance
- Patient was informed of the study and w gave their consent
- Patient on the lung transplant list
- Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team
- Patients with chronic lung disease with parenchymal dysfunctions (Chronic obstructive pulmonary disease or COPD, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or BOOP)
Who cannot join
- Minor patients
- Patient under judicial protection, under guardianship
- Patient in exclusion period (determined by a previous study or in progress)
- Patient participating in parallel in another clinical trial that may interfere with the results of the study
- Inability to give informed patient information (emergency, understanding difficulties, etc ...)
- The refusal of patient consent
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- The use of cardiopulmonary bypass during lung transplantation
- Uni-pulmonary transplant
- A transplant for idiopathic or primary pulmonary hypertension
- The presence of a cons-indication for transesophageal echocardiography:
- o Absolute contraindications:
- Abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding
- o Relative contraindications:
- ancient cervicothoracic irradiation history (> 10 years)
- recent upper gastrointestinal bleeding history
- presence of esophageal varices ≥ grade II
- zero cervical mobility
- Reflux Esophagitis
- Severe coagulation disorders
- Pregnancy / Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
Strasbourg's New Civil Hospital, Cardiac surgical reanimation department
Strasbourg, 67091
About this study
The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.
Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.
- Conditions
- Primary Lung Graft Dysfunction
- Being tested
- transoesophageal echocardiography
- Keywords
- Right ventricle, Pulmonary transplantation, Strain, isovolumic acceleration (IVA)
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoesophageal echocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| All patient | Experimental | Only one arm has been specified for the protocol. This arm included all study patient (33) for which the intervention is to be administered Receives: Procedure: transoesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation
Measured: Outcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation
Measured: utcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start5 Dec 2016
- Primary completion20 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Lung Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gharib Ajob, MD, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887560
- Sponsor's protocol ID
- 6283
- Acronym
- ETO VD PERIOP
- Status last verified
- Mar 2019
- First submitted
- 20 Jun 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.
- ClinicalTrials.gov ID
- NCT02887560
- Acronym / sponsor ID
- ETO VD PERIOP / 6283
- Conditions
- Primary Lung Graft Dysfunction
- Keywords
- Right ventricle, Pulmonary transplantation, Strain, isovolumic acceleration (IVA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 2 Sep 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.
The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.
Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient | Experimental | Procedure: transoesophageal echocardiographyOnly one arm has been specified for the protocol. This arm included all study patient (33) for which the intervention is to be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (over 18 years)
- Patient affiliated to a social protection scheme insurance
- Patient was informed of the study and w gave their consent
- Patient on the lung transplant list
- Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team
Key exclusion criteria (20 listed)
- Minor patients
- Patient under judicial protection, under guardianship
- Patient in exclusion period (determined by a previous study or in progress)
- Patient participating in parallel in another clinical trial that may interfere with the results of the study
- Inability to give informed patient information (emergency, understanding difficulties, etc ...)
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 |
|---|---|---|
| transoesophageal echocardiography | Procedure or surgery | All patient |
Primary outcome
Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation
Time frame: Outcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation
Time frame: utcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Gharib Ajob, MD principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transoesophageal echocardiography in people with Primary Lung Graft Dysfunction, run by University Hospital, Strasbourg, France 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 7 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation (time frame: Outcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.). The study lists 2 primary outcomes in all. 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 7 Mar 2019.