Morphofunctional Lung Analysis by PET and CT After Lung Transplantation
Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation
72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology.
Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Pulmonary transplantation is considered as a lifesaving procedure in end-stage pulmonary disease. However morbidity and mortality after lung transplantation are still significant.
Primary graft dysfunction (PGD) is the main cause of early death. PGD is similar to acute lung injury (ALI)/ acute respiratory distress syndrome (ARDS): oxygenation is compromised, pulmonary compliance is decreased, chest Rx shows several infiltrates, and alveolar damage is present.
25% of patients develops PGD within 72 hours from transplantation and 30 days mortality is eight times higher in patients who develop PGD.
72 hours after lung transplantation, patients, whose clinical condition allow to bring them to nuclear medicine department, will undergo pulmonary computed tomography (CT) to study lung morphology and measure lung recruitability and positron emission tomography (PET) to study lung functionality and estimate lung inflammation.
Aim of this study is to investigate the onset of PGD and other complications and to determine 72 hours and 90 days mortality after lung transplantation.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Milan
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Milano, Milan, Italien, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- lung transplantation
- ≥ 18 years
Exclusion Criteria:
- < 18 years
- patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Lung transplantated patients
Patients undergone lung transplantation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of patients alive
Tidsramme: up to 90 days from transplantation
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up to 90 days from transplantation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
incidence of complications other than primary graft dysfunction
Tidsramme: 72 hours and 90 days
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72 hours and 90 days
|
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incidence of primary graft dysfunction
Tidsramme: 72 hours and 90 days after transplantation
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72 hours and 90 days after transplantation
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: davide chiumello, md, Policlinico Hospital
- Ledende efterforsker: Franco Valenza, MD, Policlinico Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 201212
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Lidelse relateret til lungetransplantation
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The Cleveland ClinicTrukket tilbageOne Lung Ventillation (OLV) | To-lungeventilation (TLV) | Positivt End Expiratory Pressure (PEEP) | Zero End-expiratory Pressure (ZEEP)