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

NCT05877625 | Unknown DMC

• 1 other identifier: M2022419
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Acquired Infection; Ventilator-associated Pneumonia

Keywords

Environment exposure; Microbial Colonization; Microbiome

Outcome Measures

Primary Outcomes (1)

• Community of microbiome in ICU

  the dynamic changes of metagenomic/16s sequencing data

  1 year

Study Arms (3)

open ICU

open ICU: open ICU

Procedure: Expectoration care

negative ICU

negative ICU: negative-pressure laminar flow ward

Procedure: Expectoration care

positive ICU

positive ICU: laminar flow ward

Procedure: Expectoration care

Interventions

Expectoration care 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

Also known as: Bronchoscope, Oropharyngeal swabs

negative ICU; open ICU; positive ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Zhejiang University: collaborator
• Central South University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

endotracheal aspiration, bronchoalveolar lavage fluid

MeSH Terms

Conditions

Cross Infection; Pneumonia, Ventilator-Associated; Communicable Diseases

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-05

Locations

CN (1)