Lung Transplantation
Conditions
Brief summary
In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.
Interventions
PROCEDURESemi-Elective Lung Transplantation
When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Recipient inclusion criteria * Primary lung transplantation * Informed consent provided * 18-80 years old Recipient
Exclusion criteria
* Re-transplantation * Multi-organ transplantation * \>80 years old Donor inclusion criteria * Age ≤70 years old * Donor lungs are suitable to go straight to lung transplantation Donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ISHLT Primary Graft Dysfunction Grade 3 | 72 hours post-transplant |
Secondary
| Measure | Time frame |
|---|---|
| Time on ventilator | Perioperative |
| ICU and hospital length of stay | Perioperative |
| Overall survival | 30 days, 1 year post-transplant |
| Six minute walk test | 1 year post-transplant |
| Forced expiratory volume - one second (FEV1 in L) | 1 year post-transplant |
| Occurrence of acute rejection | 1 year post-transplant |
Countries
Austria, Canada, Spain
Outcome results
None listed