Biofilm Formation on Different Endotracheal Tube Materials

Study Overview
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Brief Summary
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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
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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

Official Title
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Innovation Against Infection - Device Related Infections - Part ETT

Conditions
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Respiratory Insufficiency, Ventilator-associated Pneumonia

Intervention / Treatment
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* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients needing invasive mechanical ventilation through an endotracheal tube Exclusion Criteria: Anticipated need for mechanical ventilation less than 24 hours

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biofilm formation on ETT<br>Three different endotracheal tubes uses on intubated mechanical ventilated patients will after extubation be examined regarding biofilm, structure and presence of microbes on the ETTs The different tubes will be used during consecutive time periods The study does not include any interventions concerning the treatment of these critically ill patients | Device: Endotracheal tube<br>* Three endotracheal tubes with different surfaces will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube | Pieces of the tubes examined with electron microscopy and assessed for microbes | After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Blood Cell count | Blood samples taken daily | From admission to extubation. Expected average 5 days | 
| C reactive protein | Blood samples taken daily | From admission to extubation. Expected average 5 days | 
| Length of stay, ICU and Hospital | Length of stay in Hospital and for the ICU stay | Three months from study inclusion | 
| Survival | For participating patients the status of survival or non survival at days 28 and 90 (three months) | Three months from study inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia