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ACTIVE NOT RECRUITING
NCT05761613
NA

Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia

Sponsor: Dr. John Muscedere

View on ClinicalTrials.gov

Summary

Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care costs. VAP occurs in 20% of patients and it is estimated that each case of VAP costs the health care system $10 to 15,000 Canadian. Because of its impact on patient outcomes and the health care system, VAP is regarded as an important patient safety issue and there is an urgent need for better prevention strategies. Invasive mechanical ventilation requires the passage of an endotracheal tube (ETT) through the pharynx which is frequently colonized with bacterial pathogens and a bio-film rapidly forms on the ETT. VAP results either from aspiration of contaminated oropharyngeal secretions or from aspiration of bacteria from the bio-film. In this project, the efficacy of a novel ETT coated with an antibiotic compound that has been shown to reduce the formation of bio-film and pathogen colonization will be tested. Preliminary evidence as to whether utilization of this novel ETT reduces the occurrence of VAP and improves patient outcomes will be obtained through the conduct of a pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study.

Official title: Ceragenin Coated Endotracheal Tubes for the Eradication of Ventilator Associated Pneumonia - A Prospective, Longitudinal, Cross-over, Interrupted Time, Implementation Study (CEASE VAP Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-02-21

Completion Date

2024-12-01

Last Updated

2024-04-05

Healthy Volunteers

No

Interventions

DEVICE

CeraShield Endotracheal Tube

An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)

DEVICE

Endotracheal tube with subglottic secretion drainage

An endotracheal tube with subglottic secretion drainage

Locations (1)

Kingston Health Sciences Center

Kingston, Ontario, Canada