Lung transplantatioin
Conditions
Interventions
n-NPV-EVLP group:ex-vivo lung perfusion with negative pressure ventilation
EVLP group:ex-vivo lung perfusion with positive pressure ventilation
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Recipient Inclusion Criteria: 1) Male or female patient requiring single or bilateral lung transplant; 2) 18 years of age or older; 3) To be able to provide informed consent; 2. Pre-EVLP Donor Inclusion Criteria: 1) PaO2/FiO2 lower or equal 300 mmHg; 2) Or PaO2/FiO2 > 300 mmHg and one or more of the following: Multiple blood transfusions (>=10 units) Pulmonary edema; Deemed unsuitable by PI (this must be documented in source document); 3. Post-EVLP Inclusion Criteria: 1) Surgeon clinically satisfied; 2) Stability or improvement in PVR, compliance, and airway pressures; 3) Two delta PO2 >=350 mmHg (do not have to be consecutive); 4) Or at least three of the following One delta PO2 >=350 or absolute PO2 >=400; Chest x-ray finding with absence or improvement of edema/infiltrates; Compliance-static (> 35 single, > 60 double); No consolidation on palpation.
Exclusion criteria
Exclusion criteria: 1. Pre-EVLP Donor Exclusion Criteria: 1) Significant active pneumonia and/or purulent secretions on bronchoscopy or as determined by investigator; 2) Significant aspiration of gastric contents within the lung; 3) Significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT scan or visual inspection; 4) Active infectious disease (HIV, Hep B, Hep C). 2. Post-EVLP Exclusion Criteria: 1) All delta PO2 s 10-15% functional deterioration of other lung functions with chest x-ray showing deterioration; 3) Positive for infectious disease (HIV, Hep B, Hep C).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of PGD3 within the first 72 hours after lung transplant;Mechanical ventilation time after transplantation;The survival of 6 months,12months and 24months after transplant.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day survival after transplant;Assessment of PGD at 0h, 24h and 48h after lung transplant;inflammatory cytokines at 0h, 24h, 48h and 72h after lung transplantation;Length of stay in ICU;Length of stay in hospital after transplantation;lung graft-related serious adverse events within 30 days after transplantation; | — |
Countries
China
Contacts
Public ContactZongmei Wen
Shanghai Pulmonary Hospital
Outcome results
None listed