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

Lung Transplant; Complications Clinical Trial

— FOP-TP  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165161
• Other study ID #: 2018_0098
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2023
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Lung Transplant; Complications

Intervention

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;

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of transatrial passage of contrast media	Incidence of transatrial passage of contrast media	1 day after lung transplantation
Secondary	Size of PFO, existence of an atrial septal aneurysm		1 day after lung transplantation
Secondary	Number of postoperative days with mechanical ventilation		30 days after lung transplantation
Secondary	Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia		30 days after lung transplantation
Secondary	Mortality during the stay in the intensive care unit		30 days after lung transplantation
Secondary	Mortality during the stay in the hospital		30 days after lung transplantation
Secondary	Mortality at the postoperative 30-day		30 days after lung transplantation