Clinical trial NCT06367946: Mechanism Study of Ventilator-Induced Lung Injury in Elderly People.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilator-Induced Lung Injury
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: KLK8 concentration of lung tissue
timeFrame: 2023.7.1-2024.7.1
measure: Endothelial/epithelial damage index concentration in peripheral blood
timeFrame: 2024.5.1-2024.8.1
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua hospital
Study officials:
affiliation: Department of Anesthesia, Shanghai Xinhua hospital, Shanghai China
name: Lai Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: