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Clinical Trials/NCT04165161
NCT04165161CompletedNot Applicable

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)

Hopital Foch2 sites in 1 country50 target enrollmentStarted: October 30, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Incidence of transatrial passage of contrast media
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Incidence of transatrial passage of contrast media

Time Frame: 1 day after lung transplantation

Incidence of transatrial passage of contrast media

Secondary Outcomes

  • 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)
  • Mortality during the stay in the hospital(30 days after lung transplantation)
  • Mortality at the postoperative 30-day(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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