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

P

Peking University

Status

Active, not recruiting

Conditions

Ventilator-associated Pneumonia
Hospital Acquired Infection

Treatments

Procedure: Expectoration care

Study type

Observational

Funder types

Other

Identifiers

NCT05877625
M2022419

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

180 participants in 3 patient groups

open ICU
Description:
open ICU: open ICU
Treatment:
Procedure: Expectoration care
negative ICU
Description:
negative ICU: negative-pressure laminar flow ward
Treatment:
Procedure: Expectoration care
positive ICU
Description:
positive ICU: laminar flow ward
Treatment:
Procedure: Expectoration care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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