Clinical trial NCT04242706: VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs
Official title: VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventilator-associated Pneumonia
Lead sponsor: Bactiguard AB
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled study. Two interventions:

1. Endotracheal tube with evacuation lumen without Bactiguard coating.
2. Endotracheal tube with evacuation lumen with Bactiguard coating.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAP incidence
timeFrame: Up to 28 days after inclusion
Secondary outcomes:
measure: Nosocomial infections
timeFrame: Up to 28 days after inclusion
measure: VAT incidence
timeFrame: Up to 28 days after inclusion
measure: Antibiotics consumption
timeFrame: Up to 28 days after inclusion
measure: Duration of ventilation
timeFrame: Up to 28 days after inclusion
measure: Duration of ICU and hospital stay
timeFrame: Up to 28 days after inclusion
measure: Mortality
timeFrame: Up to 60 days after inclusion
measure: Tracheal bacterial colonization
timeFrame: Up to 28 days after inclusion
measure: VAC and iVAC
timeFrame: Up to 28 days after inclusion
Other outcomes:
measure: Evaluation of microbial data
timeFrame: Up to 28 days of intubation after inclusion
measure: Evaluation of durability of the coating metals at the surface during use
timeFrame: Up to 28 days of intubation after inclusion
Locations:
city: Liege
country: Belgium
facility: Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman Liège
Study officials:
affiliation: CHU, Liege; Belgium
name: Benoit Misset, MD,Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damas P, Legrain C, Lambermont B, Dardenne N, Guntz J, Kisoka G, Demaret P, Rousseau AF, Jadot L, Piret S, Noirot D, Bertrand A, Donneau AF, Misset B. Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study. Ann Intensive Care. 2022 Jan 4;12(1):1. doi: 10.1186/s13613-021-00961-y.