VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs

Study Overview
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Brief Summary
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The study objective is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard coating. The study is randomized, prospective, controlled and blinded. All adult patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study.

Detailed Description
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The aim of the study is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard Infection Protection (BIP) coating. VAP is likely to occur in 10-20% of patients who are ventilated for at least 48 hours. These patients face a mortality risk estimated to be twice as high compared with similar ICU patients without VAP. Furthermore, VAP results in an average excess length of ICU stay with high hospital cost. Bactiguard has developed an endotracheal tube coated with a thin layer of non-releasing metals (gold, silver and palladium) firmly attached to the surface. This Bactiguard coating is tissue friendly and aims to achieve an optimal combination of anti-infective properties to reduce biofilm formation, colonization and subsequent respiratory infection. Bactiguard coated urinary products have been on market since 1995 (initially in US, then also in Japan & Europe) and used in a large number of clinical studies and evaluations, showing reduction of urinary tract infections and also antibiotics use. A BIP ETT (without evacuation lumen) clinical safety and tolerability study was performed at Karolinska University Hospital during 20128. The study showed that BIP ETT is safe, well tolerable and performs well in clinical settings. The present study of BIP ETT with evacuation lumen is randomized, prospective, controlled and blinded. All adult ICU patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study. 300 patients in total will be used to determine baselines levels (150 in each group). The study tubes will be available not only in the ICUs but also in the emergency department, including the emergency vehicles, and in every hospital wards. The study tubes will not be available in the operating rooms except in the Post Anesthesia Care Units (PACU) and Recovery rooms.

Official Title
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VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube

Conditions
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Ventilator-associated Pneumonia

Intervention / Treatment
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* Device: ETTEvac
* Device: BIP ETTEvac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intubation with a study tube and a presumed duration of ventilation for more than 24h, age > 18 y, signed informed consent Exclusion Criteria: tracheostomized patient life expectancy less than 48h, previous participation in the study pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Controlled study. Two interventions: Endotracheal tube with evacuation lumen without Bactiguard coating. Endotracheal tube with evacuation lumen with Bactiguard coating.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Endotracheal tube with evacuation lumen without Bactiguard coating. | Device: ETTEvac<br>* Endotracheal tube with evacuation lumen without noble metal coating<br>|
| Experimental: Experimental group<br>Endotracheal tube with evacuation lumen with Bactiguard coating. | Device: BIP ETTEvac<br>* Endotracheal tube with evacuation lumen with noble metal coating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAP incidence | Ventilator Associated Pneumonia incidence | Up to 28 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nosocomial infections | Incidence of any kind of nosocomial infection | Up to 28 days after inclusion | 
| VAT incidence | Ventilator Associated Tracheabronchitis incidence | Up to 28 days after inclusion | 
| Antibiotics consumption |  | Up to 28 days after inclusion | 
| Duration of ventilation | Days of intubation with study tube | Up to 28 days after inclusion | 
| Duration of ICU and hospital stay |  | Up to 28 days after inclusion | 
| Mortality |  | Up to 60 days after inclusion | 
| Tracheal bacterial colonization | Incidence of tracheal bacterial colonization reaching a CFU Count 10^6 CFU/ml | Up to 28 days after inclusion | 
| VAC and iVAC | Ventilator associated Condition and infectious iVAC | Up to 28 days after inclusion |