Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study

NCT06922916 — Not yet recruiting, 250 participants, Zhejiang University

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RegistryNCT06922916
StatusNot yet recruiting
Study typeObservational
Enrollment250 (Estimated)
SponsorZhejiang University (Other)
ConditionsCOPD, Interstitial Pneumonia, Bronchiectasis, Respiratory Failure, Idiopathic Pulmonary Fibrosis (IPF), Silicosis, Pulmonary Tuberculosis, Pulmonary Hypertension, Pulmonary Heart Disease
Datesstart 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
Locations1 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

ArmTypeInterventionsDescription
Lung transplantation groupIn 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)

FacilityCityCountryStatus
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000Hangzhou, ZhejiangChina