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

NCT ID: NCT05877625

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Hospital Acquired Infection Ventilator-associated Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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open ICU

open ICU: open ICU

Expectoration care

Intervention Type PROCEDURE

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

negative ICU

negative ICU: negative-pressure laminar flow ward

Expectoration care

Intervention Type PROCEDURE

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

positive ICU

positive ICU: laminar flow ward

Expectoration care

Intervention Type PROCEDURE

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

Interventions

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Expectoration 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

Intervention Type PROCEDURE

Other Intervention Names

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Bronchoscope Oropharyngeal swabs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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M2022419

Identifier Type: -

Identifier Source: org_study_id

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