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

Ventilator-associated Pneumonia Clinical Trial

— VITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242706
• Other study ID #: PL-13674
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2018
• Est. completion date: May 8, 2020

Study information

• Verified date: January 2021
• Source: Bactiguard AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Device:
• ETTEvac
Endotracheal tube with evacuation lumen without noble metal coating
• BIP ETTEvac
Endotracheal tube with evacuation lumen with noble metal coating

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)	Liege
Belgium	Centre Hospitalier Universitaire Sart Tilman Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Bactiguard AB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of microbial data	Amount and type of bacteria, resistance pattern	Up to 28 days of intubation after inclusion
Other	Evaluation of durability of the coating metals at the surface during use		Up to 28 days of intubation after inclusion
Primary	VAP incidence	Ventilator Associated Pneumonia incidence	Up to 28 days after inclusion
Secondary	Nosocomial infections	Incidence of any kind of nosocomial infection	Up to 28 days after inclusion
Secondary	VAT incidence	Ventilator Associated Tracheabronchitis incidence	Up to 28 days after inclusion
Secondary	Antibiotics consumption		Up to 28 days after inclusion
Secondary	Duration of ventilation	Days of intubation with study tube	Up to 28 days after inclusion
Secondary	Duration of ICU and hospital stay		Up to 28 days after inclusion
Secondary	Mortality		Up to 60 days after inclusion
Secondary	Tracheal bacterial colonization	Incidence of tracheal bacterial colonization reaching a CFU Count 10^6 CFU/ml	Up to 28 days after inclusion
Secondary	VAC and iVAC	Ventilator associated Condition and infectious iVAC	Up to 28 days after inclusion