Biofilm Formation on Different Endotracheal Tube Materials

Innovation Against Infection - Device Related Infections - Part ETT

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Ventilator-associated Pneumonia
• Intervention / Treatment: Device: Endotracheal tube

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE 221 85
    • Intensive Care Unit, Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion Criteria:

• Anticipated need for mechanical ventilation less than 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Endotracheal tube; Three endotracheal tubes with different surfaces will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Vinnova; Bactiguard AB
• Investigators: Principal Investigator: Bengt Klarin, MD, PhD, Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden

Publications and helpful links

General Publications

• 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.

Helpful Links

• Sweden's innovation agency
• (Statens Provningsanstalt) SP Technical Research Institute of Sweden,

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Biofilm; Critical illness; Ventilator-associated pneumonia; Mechanical ventilation; ETT
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Respiratory Insufficiency; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: IMI-ETT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be published as an article in a scientific journal