Biofilm Formation on Different Endotracheal Tube Materials
NCT ID: NCT02284438
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2014-04-30
2020-02-29
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Biofilm formation on ETT
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
Endotracheal tube
Three endotracheal tubes with different surfaces will be used
Interventions
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Endotracheal tube
Three endotracheal tubes with different surfaces will be used
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vinnova
OTHER_GOV
Bactiguard AB
INDUSTRY
Region Skane
OTHER
Responsible Party
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Bengt Klarin
MD Consultant
Principal Investigators
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Bengt Klarin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden
Locations
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Intensive Care Unit, Lund University Hospital
Lund, , Sweden
Countries
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References
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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.
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.
Related Links
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Sweden's innovation agency
(Statens Provningsanstalt) SP Technical Research Institute of Sweden,
Other Identifiers
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IMI-ETT
Identifier Type: -
Identifier Source: org_study_id
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