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

NCT ID: NCT04165161

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2022-08-30

Brief Summary

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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

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Conditions

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Lung Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

For each patient the 4 tests will be performed in a randomized order to limit bias
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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superior without positive tele-expiratory pressure

Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure

Group Type OTHER

search for a patent foramen ovale

Intervention Type DIAGNOSTIC_TEST

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;

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

Group Type OTHER

search for a patent foramen ovale

Intervention Type DIAGNOSTIC_TEST

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;

inferior without positive tele-expiratory pressure

Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure

Group Type OTHER

search for a patent foramen ovale

Intervention Type DIAGNOSTIC_TEST

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;

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

Group Type OTHER

search for a patent foramen ovale

Intervention Type DIAGNOSTIC_TEST

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;

Interventions

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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;

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxime Davignon, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2018_0098

Identifier Type: -

Identifier Source: org_study_id

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