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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05877625
Collaborator
Zhejiang University (Other), Central South University (Other)
180
Enrollment
1
Location
13
Anticipated Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

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, we try to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment through metagenome.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Expectoration care

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. We 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 from patients with ventilator-associated pneumonia in ICU ward. With DNA high-throughput sequencing technology, we 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on Dynamic Enviromental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
open ICU

open ICU: open ICU

Procedure: Expectoration care
Endotracheal aspiration: from discarded samples after expectoration care BALF: if patients with fiber bronchoscope examination, take the rest of the BALF after examination Oropharyngeal swabs
Other Names:
  • Bronchoscope
  • Oropharyngeal swabs

    		•
    negative ICU

    negative ICU: negative-pressure laminar flow ward

    Procedure: Expectoration care
    Endotracheal aspiration: from discarded samples after expectoration care BALF: if patients with fiber bronchoscope examination, take the rest of the BALF after examination Oropharyngeal swabs
    Other Names:
  • Bronchoscope
  • Oropharyngeal swabs

    		•
    positive ICU

    positive ICU: laminar flow ward

    Procedure: Expectoration care
    Endotracheal aspiration: from discarded samples after expectoration care BALF: if patients with fiber bronchoscope examination, take the rest of the BALF after examination Oropharyngeal swabs
    Other Names:
  • Bronchoscope
  • Oropharyngeal swabs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Community of microbiome in ICU [1 year]

      the dynamic changes of metagenomic/16s sequencing data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with mechanical ventilation, age ≥18 years, anticipated ICU stay for more than 2 days, and with two or more of the following ventilator-associated pneumonia (VAP) risk factors were included in this study. VAP risk factors: age ≥ 60 years old； Poor condition; 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; Unable to tolerate intra-abdominal pressure monitoring; pregnant woman; Patients after bladder surgery; Systemic diseases and recent use of related drugs; He had a history of infectious diseases, such as tuberculosis or PPD positive. History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg); Patients with severe mental illness; Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital
    • Zhejiang University
    • Central South University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05877625
    Other Study ID Numbers:
    • M2022419
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    Environment exposure
    Microbial Colonization
    Microbiome
    Additional relevant MeSH terms:
    Pneumonia, Ventilator-Associated

    Study Results

    No Results Posted as of May 26, 2023