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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis; Respiratory Failure; Silicosis; Pulmonary Hypertension; COPD; Pulmonary Heart Disease; Pulmonary Tuberculosis; Idiopathic Pulmonary Fibrosis (IPF); Interstitial Pneumonia

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Diansan Su, Dr; Phone Number: +8618616514088; Email: diansansu@yahoo.com
• Study Contact Backup: Name: chaoqin Chen, Dr; Phone Number: +8613567148312; Email: chenchaoqin09@126.com

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310000
      • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University between January 2017 and October 2024

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung transplantation group; In this group, we collected perioperative clinical data and analyzed risk factors associated with patient outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital adverse events	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.	Collect data for an expected average about 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay	The ICU stay （days） was calculated from the time of ICU admission after surgery completion to actual discharge from the intensive care unit	Collect data for an expected average about 2 hours
Postoperative hospital stay	Postoperative hospital（days）stay after lung transplantation	Collect data for an expected average about 2 hours
In-hospital mortality	The proportion of patients who died during the initial hospitalization period following lung transplantation surgery	Collect data for an expected average about 2 hours
30-day postoperative mortality	Number of deaths within 30 days post-transplant) / (Total number of lung transplant recipients) × 100%；	Collect data for an expected average about 2 hours
90-day postoperative mortality	Number of deaths within 90 days post-transplant) / (Total number of lung transplant recipients) × 100%	Collect data for an expected average about 2 hours
The duration of endotracheal intubation	Duration of intubation should be recorded from surgery end-time to extubation	Collect data for an expected average about 2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 3 Primary Graft Dysfunction (PGD)	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.	Collect data for an expected average about 2 hours
Pulmonary Infection	Radiologically confirmed by a staff radiologist as new or progressive pulmonary infiltrates on: Chest X-ray or Computed tomography (CT) scan	Collect data for an expected average about 2 hours
Acute Kidney Injury	A rise in serum creatinine >120 μmol/L	Collect data for an expected average about 2 hours
Cardiovascular Events	Acute myocardial infarction； heart failure；Cardiovascular hemorrhage；Clinically significant arrhythmias；Conduction system disorders；Cardiac arrest；Refractory hypotension due to cardiogenic sock.	Collect data for an expected average about 2 hours
Hepatic Dysfunction	Aspartate aminotransferase (AST) >34 or Alanine aminotransferase (ALT) >40 U/L;	Collect data for an expected average about 2 hours
Cerebral Infarction	Diagnosed by staff radiologists as new or progressive ischemic lesions on CT or MRI	Collect data for an expected average about 2 hours

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2025
• Primary Completion (Estimated): April 6, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Mortality; lung transplantatipn; Perioperative-related risks; In-hospital complications
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Fibrosis; Occupational Diseases; Hypertension; Actinomycetales Infections; Mycobacterium Infections; Lung Injury; Pneumoconiosis; Respiratory Insufficiency; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Hypertension, Pulmonary; Tuberculosis; Tuberculosis, Pulmonary; Bronchiectasis; Pulmonary Heart Disease; Silicosis
• Other Study ID Numbers: ZJU2025B0268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No