NCT02284438

Biofilm Formation on Different Endotracheal Tube Materials

Innovation Against Infection - Device Related Infections - Part ETT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Respiratory Insufficiency
• Ventilator-associated Pneumonia

Interventions

Type	Name	Description
DEVICE	Endotracheal tube	Three endotracheal tubes with different surfaces will be used

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-11-01
• Completion: 2020-02-01
• First posted: 2014-11-06
• Last updated: 2020-04-28

Locations

1 site across 1 country: Sweden