Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography (FOP-TP)

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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Diagnostic test: search for a patent foramen ovale

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: superior without positive tele-expiratory pressure; 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; 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;
Other: superior with 10 cmH2O positive tele-expiratory pressure; 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; 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;
Other: inferior without positive tele-expiratory pressure; 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; 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;
Other: inferior with 10 cmH2O positive tele-expiratory pressur; 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; 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;

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	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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Maxime Davignon, MD, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: 2018_0098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No