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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-associated Pneumonia
• Intervention / Treatment: Device: ETTEvac; Device: BIP ETTEvac

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium
    • Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)
  • Liège, Belgium, B-4000
    • Centre Hospitalier Universitaire Sart Tilman Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Endotracheal tube with evacuation lumen without Bactiguard coating.	Device: ETTEvac; Endotracheal tube with evacuation lumen without noble metal coating
Experimental: Experimental group; Endotracheal tube with evacuation lumen with Bactiguard coating.	Device: BIP ETTEvac; Endotracheal tube with evacuation lumen with noble metal coating

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of microbial data	Amount and type of bacteria, resistance pattern	Up to 28 days of intubation after inclusion
Evaluation of durability of the coating metals at the surface during use		Up to 28 days of intubation after inclusion

Collaborators and Investigators

• Sponsor: Bactiguard AB
• Investigators: Principal Investigator: Benoit Misset, MD,Prof., CHU, Liege; Belgium

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): May 8, 2020
• Study Completion (Actual): May 8, 2020

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: PL-13674

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No