Respiratory Insufficiency, Ventilator-associated Pneumonia
Conditions
Keywords
ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia
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
Interventions
DEVICEEndotracheal tube
Three endotracheal tubes with different surfaces will be used
Sponsors
Vinnova
Bactiguard AB
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients needing invasive mechanical ventilation through an endotracheal tube
Exclusion criteria
* Anticipated need for mechanical ventilation less than 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube | After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days | Pieces of the tubes examined with electron microscopy and assessed for microbes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| White Blood Cell count | From admission to extubation. Expected average 5 days | Blood samples taken daily |
| C reactive protein | From admission to extubation. Expected average 5 days | Blood samples taken daily |
| Length of stay, ICU and Hospital | Three months from study inclusion | Length of stay in Hospital and for the ICU stay |
| Survival | Three months from study inclusion | For participating patients the status of survival or non survival at days 28 and 90 (three months) |
Countries
Sweden
Outcome results
None listed