| Registry | NCT06922916 |
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 250 (Estimated) |
| Sponsor | Zhejiang University (Other) |
| Conditions | COPD, Interstitial Pneumonia, Bronchiectasis, Respiratory Failure, Idiopathic Pulmonary Fibrosis (IPF), Silicosis, Pulmonary Tuberculosis, Pulmonary Hypertension, Pulmonary Heart Disease |
| Dates | start 2025-04-22 (estimated), primary completion 2026-04-06 (estimated), completion 2026-04-30 (estimated), first posted 2025-04-11, last updated 2025-04-22 |
| Locations | 1 site in China |
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-Summary
This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Lung transplantation group | | | In this group, we collected perioperative clinical data and analyzed risk factors associated with patient outcomes. |
+Outcome measures
Primary outcomes
- In-hospital adverse events [Collect data for an expected average about 2 hours]: In-hospital adverse events were defined as post-transplant complications occurring prior to discharge, such as: Grade 3 PGD, respiratory infections, stroke, cardiac events, AKI, or liver impairment.
Secondary outcomes
- ICU stay [Collect data for an expected average about 2 hours]: The ICU stay (days) was calculated from the time of ICU admission after surgery completion to actual discharge from the intensive care unit
- Postoperative hospital stay [Collect data for an expected average about 2 hours]: Postoperative hospital(days)stay after lung transplantation
- In-hospital mortality [Collect data for an expected average about 2 hours]: The proportion of patients who died during the initial hospitalization period following lung transplantation surgery
- 30-day postoperative mortality [Collect data for an expected average about 2 hours]: Number of deaths within 30 days post-transplant) / (Total number of lung transplant recipients) × 100%;
- 90-day postoperative mortality [Collect data for an expected average about 2 hours]: Number of deaths within 90 days post-transplant) / (Total number of lung transplant recipients) × 100%
- The duration of endotracheal intubation [Collect data for an expected average about 2 hours]: Duration of intubation should be recorded from surgery end-time to extubation
Other outcomes
- Grade 3 Primary Graft Dysfunction (PGD) [Collect data for an expected average about 2 hours]: PGD3:A ratio of arterial oxygen partial pressure to fraction of inspired oxygen (PaO₂/FiO₂) < 200 mmHg with bilateral infiltrates on chest radiograph, or Requirement for extracorporeal life support (ECLS) within 72 hours postoperatively, or use of inhaled pulmonary vasodilators for >48 hours during mechanical ventilation.
- Pulmonary Infection [Collect data for an expected average about 2 hours]: Radiologically confirmed by a staff radiologist as new or progressive pulmonary infiltrates on: Chest X-ray or Computed tomography (CT) scan
- Acute Kidney Injury [Collect data for an expected average about 2 hours]: A rise in serum creatinine >120 μmol/L
- Cardiovascular Events [Collect data for an expected average about 2 hours]: Acute myocardial infarction; heart failure;Cardiovascular hemorrhage;Clinically significant arrhythmias;Conduction system disorders;Cardiac arrest;Refractory hypotension due to cardiogenic sock.
- Hepatic Dysfunction [Collect data for an expected average about 2 hours]: Aspartate aminotransferase (AST) >34 or Alanine aminotransferase (ALT) >40 U/L;
- Cerebral Infarction [Collect data for an expected average about 2 hours]: Diagnosed by staff radiologists as new or progressive ischemic lesions on CT or MRI
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Age >18 years at time of transplantation
* Received single or bilateral lung transplantation
Exclusion Criteria:
* Re-transplantation
* Multi-organ transplantation
* Autotransplantation
* Incomplete medical records: Recipients with >20% missing essential data elements in any of these categories:Preoperative baseline characteristics; Intraoperative parameters;Postoperative outcome measures
+Locations (1)
| Facility | City | Country | Status |
|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000 | Hangzhou, Zhejiang | China | |