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

Ventilator-Induced Lung Injury Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367946
• Other study ID #: XH-24-0093
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Lai Jiang, PhD
• Phone: 13817719616__
• Email: jianglaimz[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2027
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Xinhua hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KLK8 concentration of lung tissue	The concentration of KLK8 in lung tissue is determined by ELISA.	2023.7.1-2024.7.1
Primary	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