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| Name | Class |
|---|---|
| Vinnova | OTHER_GOV |
| Bactiguard AB | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofilm formation on ETT | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal tube | Device | Three endotracheal tubes with different surfaces will be used |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Klarin, MD, PhD | Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit, Lund University Hospital | Lund | SE 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22621676 | Background | 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. | |
| 32600373 | Derived | 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. |
| Label | URL |
|---|---|
| Sweden's innovation agency | View source |
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Results will be published as an article in a scientific journal
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053717 | Pneumonia, Ventilator-Associated |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
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| 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 |
| (Statens Provningsanstalt) SP Technical Research Institute of Sweden, | View source |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |