- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06201754
Bedside Air Quality in ICU and Clinical Outcome
Association Between Bedside Air Quality in ICU and Complications Including Hospital Acquired Infections and Arrhythmia
Study Overview
Detailed Description
Hospital acquired infections, also known as hospital acquired infections or healthcare related infections, refer to infections caused by activities related to treatment, diagnosis, or rehabilitation in the process of receiving medical services. Hospital acquired infections (HAIs) are a major global issue, and treatment may be costly. In the UK, it is estimated that as of 2017, the cost of HAIs could reach £ 1 billion per year, and hospital environments are considered to account for approximately 20% of all HAIs in terms of affecting the survival and transmission of pathogens in the environment. The hospital environment is influenced by workplace design and layout, operation and maintenance, as well as various interactions between the environment and people. Research on environmental microbial pollution indicates that various factors, including indoor air quality parameters (such as temperature, relative humidity, and ventilation), staff activities, patient conditions and visitor numbers, as well as surface types, may affect the presence of microorganisms. A very small amount of research associates virus concentration with these factors. The surfaces, air, and indoor structures including ventilation systems have been proven to serve as reservoirs for pathogens, and in some cases, these pathogens can survive for several months in hospital environments. Previous studies have utilized environmental sampling information to correlate air biomass levels, surface biomass, and HAIs incidence. Sampling of microorganisms in the air can be used to evaluate the concentration of microorganisms present in the hospital environment. Most studies use culture based methods to evaluate active microorganisms, and the microbial load in the air can be quantified using active or passive sampling methods.
The indoor air quality (IAQ) parameters in hospitals, including temperature, relative humidity, CO2 level (reflecting ventilation rate), particulate matter concentration, and particle size, are crucial for ensuring personnel health and may also affect the biological load in the environment. In indoor environments, temperature and relative humidity are the most commonly monitored indicators. However, these two parameters are associated with the survival of microorganisms, with humidity being a particularly noteworthy factor as many bacteria and fungi prefer humid environments. There is evidence to suggest that the survival rate of the virus increases when the relative humidity is below 40% RH. Although there are differences in guidance around the world, it is generally recommended to maintain room temperature between 16-25 ° C and humidity within the range of 40-60% RH. CO2 is related to the exhaled breath of relevant personnel and is often measured as an indicator of ventilation levels. Many studies have also shown that ventilation rates reflected by CO2 concentration can be used to assess the risk of airborne infections. The particulate matter in the air provides a general measure of indoor air quality (IAQ), which is related to indoor sources, activities, or outdoor conditions. Some studies suggest using particulate matter in the air as a monitoring indicator to measure air cleanliness, even when using ventilation systems in professional hospitals. The comprehensive consideration of these IAQ parameters can provide a more comprehensive understanding of the internal environmental conditions of the hospital, thereby helping to maintain the health and safety of patients and staff.
There is a close relationship between air pollution and cardiovascular disease. For a long time, scientific research has confirmed the adverse effects of air pollution on cardiovascular health. Small particulate matter (PM2.5) and inhalable particulate matter (PM10) in the air are the main components of air pollution, which can enter the respiratory system and enter the bloodstream through alveoli. These particles are believed to have the ability to trigger inflammatory responses, which are one of the important factors leading to cardiovascular disease. Some studies suggest that air pollution may increase the risk of cardiac events, such as arrhythmia and myocardial infarction, by affecting the autonomic function of the heart. Air pollution in the ICU may have a series of adverse effects on critically ill patients, especially those with underlying heart disease or elderly patients, but there is no relevant research to confirm this.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lingtong Huang
- Phone Number: 057187216733
- Email: lingtonghuang@zju.edu.cn
Study Locations
-
-
-
Pinghu, China
- Not yet recruiting
- The First People's Hospital of Pinghu
-
Contact:
- Lin Zhong, MD
- Email: zhonglin9393@126.com
-
Taizhou, China
- Recruiting
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
-
Contact:
- Yongpo Jiang, MD
- Email: 7719@enzemed.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- First Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Xin Huang, MD
- Phone Number: 0571-87233418
- Email: zyiitlunli@163.com
-
Principal Investigator:
- Lingtong Huang, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater than 18 years old
- The subject or their family members fully understand the patient's instructions and sign an informed consent form
Exclusion Criteria:
- Expected ICU hospitalization days are less than 2 days
- Pregnant women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ICU patients
We will include all ICU inpatients who undergo bedside air quality monitoring
|
Measure air quality, including PM2.5、PM10
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PM2.5 exposures and hospital acquired infections
Time Frame: six month
|
The correlation between the total amount or number of PM2.5 exposures (area under the curve and greater than 5ug/m3) and hospital acquired infections after admission to the ICU
|
six month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Air quality indicators and arrhythmias
Time Frame: six month
|
Correlation between air quality indicators (PM2.5, PM10) and newly diagnosed arrhythmias
|
six month
|
Medical operations and air quality indicators
Time Frame: six month
|
Correlation between medical operations and air quality indicators (PM2.5, PM10)
|
six month
|
PM10, CO2 and hospital acquired infections
Time Frame: six month
|
Correlation between PM10 and hospital acquired infections
|
six month
|
Air quality indicators and mechanical ventilation
Time Frame: six month
|
Correlation between air quality indicators (PM2.5, PM10) and mechanical ventilation
|
six month
|
Air quality indicators and the use of vasoactive drugs
Time Frame: six month
|
Correlation between air quality indicators (PM2.5, PM10) and the use of vasoactive drugs
|
six month
|
Air quality indicators and ventilator-associated pneumonia
Time Frame: six month
|
Correlation between air quality indicators (PM2.5, PM10) and incidence rate of ventilator-associated pneumonia
|
six month
|
Air quality indicators and incidence rate of CRBSI
Time Frame: six month
|
Correlation between air quality indicators (PM2.5, PM10) and incidence rate of CRBSI
|
six month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lingtong Huang, First affiliated Hospital of Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT20230456B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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