Lung Transplant; ComplicationsFOP-TPNCT04165161
Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography
A study testing search for a patent foramen ovale in people with Lung Transplant; Complications, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- search for a patent foramen ovale
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnant or lactating women
- Having a contraindication to the insertion of the esophageal ultrasound probe
- deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Lung Transplant; Complications
- Being tested
- search for a patent foramen ovale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
search for a patent foramen ovaleDiagnostic 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;
| Study group | Role | What they receive |
|---|---|---|
| superior without positive tele-expiratory pressure | Other | Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure Receives: Diagnostic Test: search for a patent foramen ovale |
| superior with 10 cmH2O positive tele-expiratory pressure | Other | Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure Receives: Diagnostic Test: search for a patent foramen ovale |
| inferior without positive tele-expiratory pressure | Other | Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure Receives: Diagnostic Test: search for a patent foramen ovale |
| inferior with 10 cmH2O positive tele-expiratory pressur | Other | Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure Receives: Diagnostic Test: search for a patent foramen ovale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transatrial passage of contrast media
Incidence of transatrial passage of contrast media
Measured: 1 day after lung transplantation
Secondary outcomes (6)
Size of PFO, existence of an atrial septal aneurysm
Measured: 1 day after lung transplantation
Number of postoperative days with mechanical ventilation
Measured: 30 days after lung transplantation
Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia
Measured: 30 days after lung transplantation
Mortality during the stay in the intensive care unit
Measured: 30 days after lung transplantation
Mortality during the stay in the hospital
Measured: 30 days after lung transplantation
Mortality at the postoperative 30-day
Measured: 30 days after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Oct 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For each patient the 4 tests will be performed in a randomized order to limit bias
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Davignon, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165161
- Sponsor's protocol ID
- 2018_0098
- Acronym
- FOP-TP
- Status last verified
- Jun 2024
- First submitted
- 29 Oct 2019
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04165161
- Acronym / sponsor ID
- FOP-TP / 2018_0098
- Conditions
- Lung Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- For each patient the 4 tests will be performed in a randomized order to limit bias
| Arm | Type | Receives |
|---|---|---|
| superior without positive tele-expiratory pressure | Other | Diagnostic Test: search for a patent foramen ovaleDiagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure |
| superior with 10 cmH2O positive tele-expiratory pressure | Other | Diagnostic Test: search for a patent foramen ovaleDiagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure |
| inferior without positive tele-expiratory pressure | Other | Diagnostic Test: search for a patent foramen ovaleDiagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure |
| inferior with 10 cmH2O positive tele-expiratory pressur | Other | Diagnostic Test: search for a patent foramen ovaleDiagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Having a contraindication to the insertion of the esophageal ultrasound probe
- deprived of liberty or under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| search for a patent foramen ovaleInjection 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; | Diagnostic test | inferior with 10 cmH2O positive tele-expiratory pressur, inferior without positive tele-expiratory pressure, superior with 10 cmH2O positive tele-expiratory pressure, superior without positive tele-expiratory pressure |
Primary outcome
Incidence of transatrial passage of contrast media
Time frame: 1 day after lung transplantation
Incidence of transatrial passage of contrast media
6 secondary outcomes
Size of PFO, existence of an atrial septal aneurysm
Time frame: 1 day after lung transplantation
Number of postoperative days with mechanical ventilation
Time frame: 30 days after lung transplantation
Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia
Time frame: 30 days after lung transplantation
Mortality during the stay in the intensive care unit
Time frame: 30 days after lung transplantation
Mortality during the stay in the hospital
Time frame: 30 days after lung transplantation
Mortality at the postoperative 30-day
Time frame: 30 days after lung transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Davignon, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing search for a patent foramen ovale in people with Lung Transplant; Complications, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of transatrial passage of contrast media (time frame: 1 day after lung transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.