Skip to content

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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04165161
Acronym
FOP-TP
Enrollment
50
Registered
2019-11-15
Start date
2019-10-30
Completion date
2022-08-30
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant; Complications

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.

Interventions

DIAGNOSTIC_TESTsearch 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;

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of transatrial passage of contrast media1 day after lung transplantationIncidence of transatrial passage of contrast media

Secondary

MeasureTime frame
Number of postoperative days with mechanical ventilation30 days after lung transplantation
Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia30 days after lung transplantation
Size of PFO, existence of an atrial septal aneurysm1 day after lung transplantation
Mortality during the stay in the hospital30 days after lung transplantation
Mortality at the postoperative 30-day30 days after lung transplantation
Mortality during the stay in the intensive care unit30 days after lung transplantation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026