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Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography (FOP-TP)

Primary Purpose

Lung Transplant; Complications

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
search for a patent foramen ovale
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Transplant; Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

superior without positive tele-expiratory pressure

superior with 10 cmH2O positive tele-expiratory pressure

inferior without positive tele-expiratory pressure

inferior with 10 cmH2O positive tele-expiratory pressur

Arm Description

Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure

Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure

Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure

Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure

Outcomes

Primary Outcome Measures

Incidence of transatrial passage of contrast media
Incidence of transatrial passage of contrast media

Secondary Outcome Measures

Size of PFO, existence of an atrial septal aneurysm
Number of postoperative days with mechanical ventilation
Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia
Mortality during the stay in the intensive care unit
Mortality during the stay in the hospital
Mortality at the postoperative 30-day

Full Information

First Posted
October 29, 2019
Last Updated
June 13, 2023
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT04165161
Brief Title
Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant; Complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
For each patient the 4 tests will be performed in a randomized order to limit bias
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
superior without positive tele-expiratory pressure
Arm Type
Other
Arm Description
Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure
Arm Title
superior with 10 cmH2O positive tele-expiratory pressure
Arm Type
Other
Arm Description
Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure
Arm Title
inferior without positive tele-expiratory pressure
Arm Type
Other
Arm Description
Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure
Arm Title
inferior with 10 cmH2O positive tele-expiratory pressur
Arm Type
Other
Arm Description
Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure
Intervention Type
Diagnostic Test
Intervention Name(s)
search for a patent foramen ovale
Intervention Description
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 Outcome Measure Information:
Title
Incidence of transatrial passage of contrast media
Description
Incidence of transatrial passage of contrast media
Time Frame
1 day after lung transplantation
Secondary Outcome Measure Information:
Title
Size of PFO, existence of an atrial septal aneurysm
Time Frame
1 day after lung transplantation
Title
Number of postoperative days with mechanical ventilation
Time Frame
30 days after lung transplantation
Title
Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia
Time Frame
30 days after lung transplantation
Title
Mortality during the stay in the intensive care unit
Time Frame
30 days after lung transplantation
Title
Mortality during the stay in the hospital
Time Frame
30 days after lung transplantation
Title
Mortality at the postoperative 30-day
Time Frame
30 days after lung transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime Davignon, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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

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