Mechanism Study of Ventilator-Induced Lung Injury in Elderly People.

Mechanism Study Under the Role of Tissue Kallikrein-related Peptidase 8 (KLK8)-Induced Senescence of Pulmonary Vascular Endothelial Cells in Ventilator-induced Lung Injury in Elderly People.

1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.
2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury
• Intervention / Treatment: Procedure: mechanical ventilation

Detailed Description

1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age. All clinical samples have been collected and tested uniformly. Correlation analysis between KLK8 and age will be performed by using Statistical Package for the Social Sciences (SPSS) 22.0 software, and P<0.05 indicates a statistically significant difference. The obtained clinical data should be recorded on survey forms, and researchers should verify patient information by recording basic information such as age and gender.
2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation. All clinical samples have been collected and tested uniformly. Correlation analysis between endothelial/epithelial damage index, age and duration of mechanical ventilation will be performed by using SPSS 22.0 software, and P<0.05 indicates a statistically significant difference. The obtained clinical data should be recorded on survey forms, and researchers should verify patient information by recording basic information such as age and gender.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lai Jiang, PhD; Phone Number: 13817719616__; Email: jianglaimz@sina.com

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Shanghai Xinhua hospital
    • Contact: Lai Jiang, PhD; Phone Number: 13817719616__; Email: jianglaimz@sina.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

We started collecting lung tissues and peripheral blood from patients with mechanical ventilation from June 2023. All clinical samples have been collected and tested uniformly. Correlation analysis between KLK8 and age using SPSS 22.0 software will be performed, and P<0.05 indicates a statistically significant difference. The obtained clinical data should be recorded on survey forms, and researchers should verify patient information by recording basic information such as age and gender.

Description

Inclusion Criteria:

1. Lung tissues from patients with different ages:

   Patients undergoing elective general anesthesia surgery; Patients undergoing partial lung resection with mechanical ventilation; American Society of Anesthesiology (ASA) grade 2-3;

2. Peripheral blood from patients with different ages and duration of mechanical ventilation:

Patients undergoing elective general anesthesia surgery with mechanical ventilation; ASA grade 2-3;

Exclusion Criteria:

1. Lung tissues from patients with different ages:

   Patients with chronic lung diseases (asthma, chronic obstructive pulmonary disease (COPD), pulmonary heart disease, etc.); Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV), or receiving immunotherapy; Patients who have recently suffered from pneumonia; Recent history of mechanical ventilation; Patients with thrombotic diseases; Children and pregnant women.

2. Peripheral blood from patients with different ages and duration of mechanical ventilation:

Patients with chronic lung diseases (asthma, COPD, pulmonary heart disease, etc.); Smoking patients; Patients with hypertension/diabetes/coronary heart disease; Patients with HIV, HBV, HCV, HDV, or receiving immunotherapy; Patients who have recently suffered from pneumonia; Recent history of mechanical ventilation; Patients with thrombotic diseases; Children and pregnant women.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Under 40 years old; Patients undergoing surgery with mechanical ventilation who are under 40 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
40-50 years old; Patients undergoing surgery with mechanical ventilation who are 40-50 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
50-60 years old; Patients undergoing surgery with mechanical ventilation who are 50-60 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
60-70 years old; Patients undergoing surgery with mechanical ventilation who are 60-70 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
70-80 years old; Patients undergoing surgery with mechanical ventilation who are 70-80 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
Over 80 years old; Patients undergoing surgery with mechanical ventilation who are over 80 years old	Procedure: mechanical ventilation; Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KLK8 concentration of lung tissue	The concentration of KLK8 in lung tissue is determined by ELISA.	2023.7.1-2024.7.1
Endothelial/epithelial damage index concentration in peripheral blood	The concentration of endothelial/epithelial damage index in lung tissue is determined by ELISA.	2024.5.1-2024.8.1

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Lai Jiang, PhD, Department of Anesthesia, Shanghai Xinhua hospital, Shanghai China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: XH-24-0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No