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

Not Applicable

Completed

• Conditions: Lung Transplant; Complications
• Interventions: Diagnostic Test: search for a patent foramen ovale

• Registration Number: NCT04165161
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study Start: 2019-10-30
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Read More

Exclusion Criteria

• Pregnant or lactating women
• Having a contraindication to the insertion of the esophageal ultrasound probe
• deprived of liberty or under guardianship

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
superior without positive tele-expiratory pressure	search for a patent foramen ovale	Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure
inferior with 10 cmH2O positive tele-expiratory pressur	search for a patent foramen ovale	Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure
inferior without positive tele-expiratory pressure	search for a patent foramen ovale	Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure
superior with 10 cmH2O positive tele-expiratory pressure	search for a patent foramen ovale	Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure

Primary Outcome Measures

Name	Time	Method
Incidence of transatrial passage of contrast media	1 day after lung transplantation	Incidence of transatrial passage of contrast media

Secondary Outcome Measures

Name	Time	Method
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
Mortality during the stay in the hospital	30 days after lung transplantation
Mortality at the postoperative 30-day	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

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France