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Biofilm Formation on Different Endotracheal Tube Materials

Primary Purpose

Respiratory Insufficiency, Ventilator-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Endotracheal tube
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Respiratory Insufficiency focused on measuring ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion Criteria:

  • Anticipated need for mechanical ventilation less than 24 hours

Sites / Locations

  • Intensive Care Unit, Lund University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biofilm formation on ETT

Arm Description

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

Outcomes

Primary Outcome Measures

Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
Pieces of the tubes examined with electron microscopy and assessed for microbes

Secondary Outcome Measures

White Blood Cell count
Blood samples taken daily
C reactive protein
Blood samples taken daily
Length of stay, ICU and Hospital
Length of stay in Hospital and for the ICU stay
Survival
For participating patients the status of survival or non survival at days 28 and 90 (three months)

Full Information

First Posted
October 21, 2014
Last Updated
April 27, 2020
Sponsor
Region Skane
Collaborators
Vinnova, Bactiguard AB
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1. Study Identification

Unique Protocol Identification Number
NCT02284438
Brief Title
Biofilm Formation on Different Endotracheal Tube Materials
Official Title
Innovation Against Infection - Device Related Infections - Part ETT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Vinnova, Bactiguard AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Ventilator-associated Pneumonia
Keywords
ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofilm formation on ETT
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Endotracheal tube
Intervention Description
Three endotracheal tubes with different surfaces will be used
Primary Outcome Measure Information:
Title
Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
Description
Pieces of the tubes examined with electron microscopy and assessed for microbes
Time Frame
After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Secondary Outcome Measure Information:
Title
White Blood Cell count
Description
Blood samples taken daily
Time Frame
From admission to extubation. Expected average 5 days
Title
C reactive protein
Description
Blood samples taken daily
Time Frame
From admission to extubation. Expected average 5 days
Title
Length of stay, ICU and Hospital
Description
Length of stay in Hospital and for the ICU stay
Time Frame
Three months from study inclusion
Title
Survival
Description
For participating patients the status of survival or non survival at days 28 and 90 (three months)
Time Frame
Three months from study inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients needing invasive mechanical ventilation through an endotracheal tube Exclusion Criteria: Anticipated need for mechanical ventilation less than 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Klarin, MD, PhD
Organizational Affiliation
Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, Lund University Hospital
City
Lund
ZIP/Postal Code
SE 221 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be published as an article in a scientific journal
Citations:
PubMed Identifier
22621676
Citation
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.
Results Reference
background
PubMed Identifier
32600373
Citation
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.
Results Reference
derived
Links:
URL
http://www.vinnova.se/en/
Description
Sweden's innovation agency
URL
http://www.sp.se/en/Sidor/default.aspx
Description
(Statens Provningsanstalt) SP Technical Research Institute of Sweden,

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Biofilm Formation on Different Endotracheal Tube Materials

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