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

Active, not recruiting

• Conditions: Ventilator-associated Pneumonia; Hospital Acquired Infection
• Interventions: Procedure: Expectoration care

• Registration Number: NCT05877625
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
positive ICU	Expectoration care	positive ICU: laminar flow ward
negative ICU	Expectoration care	negative ICU: negative-pressure laminar flow ward
open ICU	Expectoration care	open ICU: open ICU

Primary Outcome Measures

Name	Time	Method
Community of microbiome in ICU	1 year	the dynamic changes of metagenomic/16s sequencing data

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China