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

Hopital Foch

Status: Completed

Conditions: Lung Transplant; Complications

Treatments: Diagnostic Test: search for a patent foramen ovale

Study type: Interventional

Funder types: Other

Identifiers

NCT04165161

2018_0098

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

superior without positive tele-expiratory pressure

Other group

Description:

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

Treatment:

Diagnostic Test: search for a patent foramen ovale

superior with 10 cmH2O positive tele-expiratory pressure

Other group

Description:

Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure

Treatment:

Diagnostic Test: search for a patent foramen ovale

inferior without positive tele-expiratory pressure

Other group

Description:

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

Treatment:

Diagnostic Test: search for a patent foramen ovale

inferior with 10 cmH2O positive tele-expiratory pressur

Other group

Description:

Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure

Treatment:

Diagnostic Test: search for a patent foramen ovale