Ventilator-Induced Lung InjuryNCT06367946
Mechanism Study of Ventilator-Induced Lung Injury in Elderly People.
An observational study of Ventilator-Induced Lung Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator-Induced Lung Injury
- What is being tested?
- mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Xinhua hospital
Shanghai, 200000
Lai Jiang, PhD, 13817719616__, jianglaimz@sina.com
About this study
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.
- We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.
- 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.
Read the detailed description
- 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.
- 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.
- Conditions
- Ventilator-Induced Lung Injury
- Being tested
- mechanical ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
Mechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange.
| Study group | Role | What they receive |
|---|---|---|
| Under 40 years old | Patients undergoing surgery with mechanical ventilation who are under 40 years old Receives: Procedure: mechanical ventilation | |
| 40-50 years old | Patients undergoing surgery with mechanical ventilation who are 40-50 years old Receives: Procedure: mechanical ventilation | |
| 50-60 years old | Patients undergoing surgery with mechanical ventilation who are 50-60 years old Receives: Procedure: mechanical ventilation | |
| 60-70 years old | Patients undergoing surgery with mechanical ventilation who are 60-70 years old Receives: Procedure: mechanical ventilation | |
| 70-80 years old | Patients undergoing surgery with mechanical ventilation who are 70-80 years old Receives: Procedure: mechanical ventilation | |
| Over 80 years old | Patients undergoing surgery with mechanical ventilation who are over 80 years old Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
KLK8 concentration of lung tissue
The concentration of KLK8 in lung tissue is determined by ELISA.
Measured: 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.
Measured: 2024.5.1-2024.8.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jun 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Lai Jiang, PhD, Principal investigator, Department of Anesthesia, Shanghai Xinhua hospital, Shanghai China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367946
- Sponsor's protocol ID
- XH-24-0093
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06367946
- Acronym / sponsor ID
- XH-24-0093
- Conditions
- Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.
- 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
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Under 40 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are under 40 years old |
| 40-50 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are 40-50 years old |
| 50-60 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are 50-60 years old |
| 60-70 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are 60-70 years old |
| 70-80 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are 70-80 years old |
| Over 80 years old | – | Procedure: mechanical ventilationPatients undergoing surgery with mechanical ventilation who are over 80 years old |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical ventilationMechanical ventilation is machine-delivered flow of gases to both oxygenate and ventilate a patient who is unable to maintain physiological gas exchange. | Procedure or surgery | 40-50 years old, 50-60 years old, 60-70 years old, 70-80 years old, Over 80 years old, Under 40 years old |
Primary outcome
KLK8 concentration of lung tissue
Time frame: 2023.7.1-2024.7.1
The concentration of KLK8 in lung tissue is determined by ELISA.
Endothelial/epithelial damage index concentration in peripheral blood
Time frame: 2024.5.1-2024.8.1
The concentration of endothelial/epithelial damage index in lung tissue is determined by ELISA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lai Jiang, PhD principal investigator
Department of Anesthesia, Shanghai Xinhua hospital, Shanghai China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Induced Lung Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lai Jiang, PhD (13817719616__, jianglaimz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KLK8 concentration of lung tissue (time frame: 2023.7.1-2024.7.1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.