Critical IllnessNCT06201754
Bedside Air Quality in ICU and Clinical Outcome
An observational study of Critical Illness, run by First Affiliated Hospital of Zhejiang University at 3 sites in China.
Trial summary
There is a close relationship between air pollution and cardiovascular disease. Small particulate matter and inhalable particulate matter in the air are the main components of air pollution, which can enter the respiratory system and enter the bloodstream through alveoli. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Measure air quality
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 2 Jan 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: This study includes all patients in need of intensive care
Who may be able to join
- Age greater than 18 years old
- The subject or their family members fully understand the patient's instructions and sign an informed consent form
Who cannot join
- Expected ICU hospitalization days are less than 2 days
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
China3 sites
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
The First People's Hospital of Pinghu
Pinghu
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou
About this study
Official title: Association Between Bedside Air Quality in ICU and Complications Including Hospital Acquired Infections and Arrhythmia
There is a close relationship between air pollution and cardiovascular disease. Small particulate matter and inhalable particulate matter 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Measure air quality
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure air qualityOther
Measure air quality, including PM2.5、PM10
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | We will include all ICU inpatients who undergo bedside air quality monitoring Receives: Other: Measure air quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
PM2.5 exposures and hospital acquired infections
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
Measured: six month
Secondary outcomes (7)
Air quality indicators and arrhythmias
Correlation between air quality indicators (PM2.5, PM10) and newly diagnosed arrhythmias
Measured: six month
Medical operations and air quality indicators
Correlation between medical operations and air quality indicators (PM2.5, PM10)
Measured: six month
PM10, CO2 and hospital acquired infections
Correlation between PM10 and hospital acquired infections
Measured: six month
Air quality indicators and mechanical ventilation
Correlation between air quality indicators (PM2.5, PM10) and mechanical ventilation
Measured: six month
Air quality indicators and the use of vasoactive drugs
Correlation between air quality indicators (PM2.5, PM10) and the use of vasoactive drugs
Measured: six month
Air quality indicators and ventilator-associated pneumonia
Correlation between air quality indicators (PM2.5, PM10) and incidence rate of ventilator-associated pneumonia
Measured: six month
Air quality indicators and incidence rate of CRBSI
Correlation between air quality indicators (PM2.5, PM10) and incidence rate of CRBSI
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start2 Jan 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingtong Huang, MD, First Affiliated Hospital of Zhejiang University
- Investigators
- Lingtong Huang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201754
- Sponsor's protocol ID
- IIT20230456B
- Status last verified
- Aug 2025
- First submitted
- 2 Jan 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Bedside Air Quality in ICU and Complications Including Hospital Acquired Infections and Arrhythmia
- ClinicalTrials.gov ID
- NCT06201754
- Acronym / sponsor ID
- IIT20230456B
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 11 Jan 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.
There is a close relationship between air pollution and cardiovascular disease. Small particulate matter and inhalable particulate matter 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Measure air qualityWe will include all ICU inpatients who undergo bedside air quality monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study includes all patients in need of intensive care
Key inclusion criteria (2 listed)
- Age greater than 18 years old
- The subject or their family members fully understand the patient's instructions and sign an informed consent form
Key exclusion criteria (2 listed)
- Expected ICU hospitalization days are less than 2 days
- 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 |
|---|---|---|
| Measure air qualityMeasure air quality, including PM2.5、PM10 | Other | ICU patients |
Primary outcome
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
7 secondary outcomes
Air quality indicators and arrhythmias
Time frame: six month
Medical operations and air quality indicators
Time frame: six month
PM10, CO2 and hospital acquired infections
Time frame: six month
Air quality indicators and mechanical ventilation
Time frame: six month
Air quality indicators and the use of vasoactive drugs
Time frame: six month
Air quality indicators and ventilator-associated pneumonia
Time frame: six month
Air quality indicators and incidence rate of CRBSI
Time frame: six month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- 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. This study is not recruiting at the moment.
Lingtong Huang principal investigator
First Affiliated Hospital of Zhejiang University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by First Affiliated Hospital of Zhejiang University at 3 sites 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PM2.5 exposures and hospital acquired infections (time frame: six month). 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 7 Aug 2025.