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

NCT04165161 | Completed

• 1 other identifier: 2018_0098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of transatrial passage of contrast media

  Incidence of transatrial passage of contrast media

  1 day after lung transplantation

Secondary Outcomes (6)

• 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

Study Arms (4)

superior without positive tele-expiratory pressure

OTHER

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

superior with 10 cmH2O positive tele-expiratory pressure

OTHER

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

inferior without positive tele-expiratory pressure

OTHER

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

inferior with 10 cmH2O positive tele-expiratory pressur

OTHER

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

Interventions

search for a patent foramen ovale 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; inferior without positive tele-expiratory pressure; superior with 10 cmH2O positive tele-expiratory pressure; superior without positive tele-expiratory pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92151, France

Location

Study Officials

• Maxime Davignon, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For each patient the 4 tests will be performed in a randomized order to limit bias

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 15, 2019
• Study Start: October 30, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

FR (1)