Clinical trial NCT02284438: Biofilm Formation on Different Endotracheal Tube Materials
Official title: Innovation Against Infection - Device Related Infections - Part ETT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Ventilator-associated Pneumonia
Keywords: ETT
Biofilm
Mechanical ventilation
Critical illness
Ventilator-associated pneumonia
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Bactiguard AB
First posted: 2014-11-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.

Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.

Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.

Detailed description: Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.

It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.

In this study the investigators will compare microbiology and EM images in that same manner.

Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.

Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.

ICU patients needing mechanical ventilation will be intubated with the three different devices with different surfaces characteristics.

The tubes are: A - standard Poly vinyl chloride (PVC) tube; B - PVC with a silicon coating; C - PVC with a special metal film coating

Eligibility criteria: Inclusion Criteria:

* Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion Criteria:

* Anticipated need for mechanical ventilation less than 24 hours

Primary outcomes:
measure: Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
timeFrame: After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Secondary outcomes:
measure: White Blood Cell count
timeFrame: From admission to extubation. Expected average 5 days
measure: C reactive protein
timeFrame: From admission to extubation. Expected average 5 days
measure: Length of stay, ICU and Hospital
timeFrame: Three months from study inclusion
measure: Survival
timeFrame: Three months from study inclusion
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Intensive Care Unit, Lund University Hospital
Study officials:
affiliation: Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden
name: Bengt Klarin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gil-Perotin S, Ramirez P, Marti V, Sahuquillo JM, Gonzalez E, Calleja I, Menendez R, Bonastre J. Implications of endotracheal tube biofilm in ventilator-associated pneumonia response: a state of concept. Crit Care. 2012 May 23;16(3):R93. doi: 10.1186/cc11357.
citation: Thorarinsdottir HR, Kander T, Holmberg A, Petronis S, Klarin B. Biofilm formation on three different endotracheal tubes: a prospective clinical trial. Crit Care. 2020 Jun 29;24(1):382. doi: 10.1186/s13054-020-03092-1.