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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventilator-associated Pneumonia; Hospital Acquired Infection
• Intervention / Treatment: 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. 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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
open ICU; open ICU: open ICU	Procedure: Expectoration care; Endotracheal aspiration: from discarded samples after expectoration care; BALF (bronchoalveolar lavage fluid): 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 (bronchoalveolar lavage fluid): 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 (bronchoalveolar lavage fluid): if patients with fiber bronchoscope examination, take the rest of the BALF after examination; Oropharyngeal swabs; Other Names: Bronchoscope; Oropharyngeal swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community of microbiome in ICU	the dynamic changes of metagenomic/16s sequencing data	1 year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Central South University; Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 31, 2023
• Study Completion (Estimated): August 31, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Microbial Colonization; Environment exposure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: M2022419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No