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Completed

NCT Number: NCT02284438

Biofilm Formation on Different Endotracheal Tube Materials

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion criteria

  • Anticipated need for mechanical ventilation less than 24 hours

Treatment and study plan

Endotracheal tube

Device

Three endotracheal tubes with different surfaces will be used

Primary outcomes

  1. Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube

    Time frame: 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 outcomes

  1. White Blood Cell count

    Time frame: From admission to extubation. Expected average 5 days

    Blood samples taken daily

  2. C reactive protein

    Time frame: From admission to extubation. Expected average 5 days

    Blood samples taken daily

  3. Length of stay, ICU and Hospital

    Time frame: Three months from study inclusion

    Length of stay in Hospital and for the ICU stay

  4. Survival

    Time frame: Three months from study inclusion

    For participating patients the status of survival or non survival at days 28 and 90 (three months)

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Bactiguard AB
  • Vinnova

Registry information

Official study title

Innovation Against Infection - Device Related Infections - Part ETT

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Nov 6, 2014
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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