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Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host

Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05877625
Enrollment
180
Registered
2023-05-26
Start date
2022-08-01
Completion date
2023-08-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Acquired Infection, Ventilator-associated Pneumonia

Keywords

Environment exposure, Microbial Colonization, Microbiome

Brief summary

HAI (Hospital-acquired infection) is very common in ICU,and lack of understanding of environmental exposure omics and environment-host microbial interactions restricts the prevention and control of HAI. In this project, the investigators try to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment through metagenome.

Detailed description

This observational study aims to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment. The investigators will conduct weekly air microbiome sampling and microbiome sampling at 5 high-frequency contact points in different types of ICU units in three hospitals for one consecutive year, and collect dynamic pharyngeal swabs from ICU ward health care workers and dynamic clinical specimens (endotracheal aspiration, and bronchoalveolar lavage fluid) from patients with ventilator-associated pneumonia in ICU ward. With DNA high-throughput sequencing technology, the investigators will analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment, and provide support for HAI prevention.

Interventions

PROCEDUREExpectoration care

1. Endotracheal aspiration: from discarded samples after expectoration care 2. BALF (bronchoalveolar lavage fluid): if patients with fiber bronchoscope examination, take the rest of the BALF after examination 3. Oropharyngeal swabs

Sponsors

Zhejiang University
CollaboratorOTHER
Central South University
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* With mechanical ventilation * Age ≥18 years * Anticipated ICU stay for more than 2 days * With two or more of the following ventilator-associated pneumonia (VAP) risk factors * VAP risk factors: Age ≥ 60 years old; Patients with chronic lung disease; Long-term bedridden; Unconsciousness; Sputum is not easily coughed up; Antibiotics have been used before mechanical ventilation; Long-term use of H receptor blockers and proton pump inhibitors.

Exclusion criteria

* Patients who have not signed the informed consent * Pregnant * Systemic diseases and recent use of related drugs * History of infectious diseases, such as tuberculosis or PPD positive * History of hypertension and poor blood pressure control (SBP / DBP \> = 140mmHg) * With severe mental illness * Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc.

Design outcomes

Primary

MeasureTime frameDescription
Community of microbiome in ICU1 yearthe dynamic changes of metagenomic/16s sequencing data

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026