Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia (CEASEVAP)

Dr. John Muscedere

Status: Active, not recruiting

Conditions: Ventilator Associated Pneumonia

Treatments: Device: CeraShield Endotracheal Tube; Device: Endotracheal tube with subglottic secretion drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT05761613

6036323

Details and patient eligibility

About

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.

Full description

The innovation that is being studied is a novel antibiotic coated endotracheal tube (ETT) for the prevention of ventilator associated pneumonia (VAP) in critically ill, mechanically ventilated patients. The novel ETT is the CeraShield ETT consisting of a standard ETT with an antimicrobial hydrophilic coating containing ceragenins (CSAs) on the inner and outer lumen of the device, as well as the inflatable cuff. The CSA coating on the CeraShield protects it from microbial colonization and bio-film growth. The CSA ETT is otherwise equivalent to standard ETT tubes currently in use and is licensed in Canada for clinical use as a Class 2 device.

1. It is hypothesized that CSA coated ETTs will reduce the incidence of Ventilator Associated Pneumonia and improve clinical outcomes including antibiotic utilization when compared to ETTs currently in use.
2. It is hypothesized that a definitive cluster randomized multi-center study is feasible and supported by the data from this study.

To test the hypotheses, an Interrupted Time Series Cross-Over Implementation Study will be used to provide preliminary evidence of the efficacy of the CeraShield ETT compared to the ETT currently used at the study center in critically ill mechanically ventilated patients. This study will inform and be modified to conduct a future large multi-center cluster randomized study.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult critically ill patients with respiratory failure requiring intubation

Exclusion criteria

1. Admission to hospital or ICU with a non-study ETT already in place
2. Presence of a tracheostomy on ICU admission
3. Unable to be intubated with non-study ETT
4. Declined participation in research or data collection

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Endotracheal Tube with Subglottic Secretion Drainage

Active Comparator group

Description:

All patients in this arm will be intubated with an ETT with subglottic secretion drainage

Treatment:

Device: Endotracheal tube with subglottic secretion drainage

CeraShield Endotracheal Tube

Active Comparator group

Description:

All patients in this arm will be intubated with a ceragenin coated ETT

Treatment:

Device: CeraShield Endotracheal Tube