Biofilm Formation on Different Endotracheal Tube Materials

NCT02284438 | Completed

• 1 other identifier: IMI-ETT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Ventilator-associated Pneumonia

Keywords

ETT; Biofilm; Mechanical ventilation; Critical illness; Ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• White Blood Cell count

  From admission to extubation. Expected average 5 days

• C reactive protein

  From admission to extubation. Expected average 5 days

• Length of stay, ICU and Hospital

  Three months from study inclusion

• Survival

  Three months from study inclusion

Study Arms (1)

Biofilm formation on ETT

OTHER

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

Interventions

Endotracheal tube DEVICE

Three endotracheal tubes with different surfaces will be used

Biofilm formation on ETT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients needing invasive mechanical ventilation through an endotracheal tube

You may not qualify if:

• Anticipated need for mechanical ventilation less than 24 hours

Sponsors & Collaborators

• Region Skane: lead
• Vinnova: collaborator
• Bactiguard AB: collaborator

Study Sites (1)

Intensive Care Unit, Lund University Hospital

Lund, SE 221 85, Sweden

Location

Related Publications (2)

• 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.

  PMID: 22621676 BACKGROUND

• 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.

  PMID: 32600373 DERIVED

Related Links

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

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia, Ventilator-Associated; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bengt Klarin, MD, PhD

  Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Consultant

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 6, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2020
• Last Updated: April 28, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)