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

NCT06367946 | Recruiting

• 1 other identifier: XH-24-0093
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.
2. 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.

Conditions

Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

Under 40 years old

Patients undergoing surgery with mechanical ventilation who are under 40 years old

Procedure: mechanical ventilation

40-50 years old

Patients undergoing surgery with mechanical ventilation who are 40-50 years old

Procedure: mechanical ventilation

50-60 years old

Patients undergoing surgery with mechanical ventilation who are 50-60 years old

Procedure: mechanical ventilation

60-70 years old

Patients undergoing surgery with mechanical ventilation who are 60-70 years old

Procedure: mechanical ventilation

70-80 years old

Patients undergoing surgery with mechanical ventilation who are 70-80 years old

Procedure: mechanical ventilation

Over 80 years old

Patients undergoing surgery with mechanical ventilation who are over 80 years old

Procedure: mechanical ventilation

Interventions

mechanical ventilation PROCEDURE

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; 50-60 years old; 60-70 years old; 70-80 years old; Over 80 years old; Under 40 years old

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Xinhua hospital

Shanghai, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Lung tissues from patients undergoing partial lung resection surgery 2. Peripheral blood from patients undergoing general anesthesia surgery with mechanical ventilation before mechanical ventilation and after mechanical ventilation

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Lai Jiang, PhD

  Department of Anesthesia, Shanghai Xinhua hospital, Shanghai China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai Jiang, PhD

CONTACT

13817719616__; jianglaimz@sina.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 021-25077820

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: June 1, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)