Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.

Official Title
-----------------
Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)

Conditions
-----------------
Lung Transplant; Complications

Intervention / Treatment
-----------------
* Diagnostic Test: search for a patent foramen ovale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years old minimum Benefiting from a lung transplant Having an upper vena cava catheter and a lower vena cava catheter set up as part of the usual care Having signed a consent form Affiliated to a insurance scheme or beneficiary (excluding AME) Exclusion Criteria: Pregnant or lactating women Having a contraindication to the insertion of the esophageal ultrasound probe deprived of liberty or under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: For each patient the 4 tests will be performed in a randomized order to limit bias
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: superior without positive tele-expiratory pressure<br>Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure | Diagnostic Test: search for a patent foramen ovale<br>* Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;<br>|
| Other: superior with 10 cmH2O positive tele-expiratory pressure<br>Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure | Diagnostic Test: search for a patent foramen ovale<br>* Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;<br>|
| Other: inferior without positive tele-expiratory pressure<br>Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure | Diagnostic Test: search for a patent foramen ovale<br>* Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;<br>|
| Other: inferior with 10 cmH2O positive tele-expiratory pressur<br>Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure | Diagnostic Test: search for a patent foramen ovale<br>* Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of transatrial passage of contrast media | Incidence of transatrial passage of contrast media | 1 day after lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of PFO, existence of an atrial septal aneurysm |  | 1 day after lung transplantation | 
| Number of postoperative days with mechanical ventilation |  | 30 days after lung transplantation | 
| Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia |  | 30 days after lung transplantation | 
| Mortality during the stay in the intensive care unit |  | 30 days after lung transplantation | 
| Mortality during the stay in the hospital |  | 30 days after lung transplantation | 
| Mortality at the postoperative 30-day |  | 30 days after lung transplantation |