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OpenTrials
Completed

NCT Number: NCT04165161

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

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.

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Key information

Conditions

Lung Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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;

Primary outcomes

  1. Incidence of transatrial passage of contrast media

    Time frame: 1 day after lung transplantation

    Incidence of transatrial passage of contrast media

Secondary outcomes

  1. Size of PFO, existence of an atrial septal aneurysm

    Time frame: 1 day after lung transplantation

  2. Number of postoperative days with mechanical ventilation

    Time frame: 30 days after lung transplantation

  3. Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia

    Time frame: 30 days after lung transplantation

  4. Mortality during the stay in the intensive care unit

    Time frame: 30 days after lung transplantation

  5. Mortality during the stay in the hospital

    Time frame: 30 days after lung transplantation

  6. Mortality at the postoperative 30-day

    Time frame: 30 days after lung transplantation

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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)

Acronym: FOP-TP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2019
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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