Infection Control Program in Tracheostomized Patients

March 2, 2022 updated by: Hanaa Aref, Assiut University

Efficacy of Infection Control Program on Reducing Tracheostomy Tube Colonization With Biofilm Producing Antimicrobial Resistant Bacteria

Healthcare-associated infections are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting and are not present at the time of admission. Medical instrumentation increases the risk of development of HAIs. Such devices include, venous and urinary catheters, and ventilators.

Most ventilator-dependent patients undergo respiratory stabilization with an endotracheal tube in a critical care setting. Later on, translaryngeal tubes are converted to a tracheostomy to provide long-term airway access for ventilatory support.

Tracheostomy is a commonly performed airway surgery for critically ill patients. It has variable complications, a common one being secondary infection with bacteria and fungi, which in turn leads- to granulation formation in stoma and on peristomal region.

The risk factor for infection in patients with tracheostomy occurs due to exposure to large amounts of bacteria because they do not pass through the upper airway defense system.

The commonest microorganism colonizing the tracheostomy tube leading to respiratory infections include Pseudomonas aeurginosa, Acinetobacter baumanii, and methicillin resistant Staphylococcus aureus, some of these organisms are antibiotic resistant.

Biofilm formation is a unique self-protective mechanism of bacteria, protects them from host immune response and antimicrobial agents. Studies showed that more than 60% of hospital acquired infections are caused by biofilm forming bacteria on medical devices. These infections are most commonly attributed to Staphylococcus aureus, Pseudomonas, and mixed flora.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Healthcare-associated infections (HAIs) are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting and are not present or incubating at the time of admission. Medical instrumentation increases the risk of development of HAIs and most patients admitted for health care are exposed to some kind of medical device in the course of their treatment. Such devices include, but are not limited to, venous and urinary catheters, and ventilators.

Most ventilator-dependent patients first undergo respiratory stabilization with a translaryngeal endotracheal tube in a critical care setting. At some time during the course of their disease, translaryngeal tubes are converted to a tracheostomy to provide long-term airway access for ventilatory support.

Tracheostomy is a commonly performed airway surgery for critically ill patients. It is a lifesaving procedure done for mechanical ventilation, bronchopulmonary toileting and reduce pulmonary effort.

Tracheostomy tubes have a main shaft (cannula) attached to a neck plate (or flange), and cuffed tubes have a pilot balloon, which shows whether the cuff is inflated. The neck plate has a slot where ties can be placed, and fenestrated tubes can have a cuff and/or inner cannula. Their insertion is aided with an obturator.

It has variable complications, a common one being secondary infection with bacteria and fungi, which in turn leads- to granulation formation in stoma and on peristomal region. As tracheostomy tube is an indwelling prosthesis, it provides potential surface for growth of bacteria.

In tracheostomized patients, the role of the nose, nasopharynx and upper respiratory mucosa as a defensive mechanism is absent which allows bacteria to have direct access from the stoma to the respiratory tract. Infections in tracheostomy stoma, tracheobronchitis, and pneumonia are common infections that occur after tracheostomy. The risk factor for infection in patients with tracheostomy occurs due to exposure to large amounts of bacteria because they do not pass through the upper airway defense system.

There is a 20 fold increase in the development of respiratory tract infection following mechanical ventilation in tracheostomized or mechanically ventilated patients, the incidence vary between 4% and 28%. The commonest microorganism colonizing the tracheostomy tube leading to respiratory infections include Pseudomonas aeurginosa, Acinetobacter baumanii, and methicillin resistant Staphylococcus aureus, some of these organisms are antibiotic resistant which in turn increase the morbidity and costs involved.

The tracheal cannula is often be exposed to enzymes, antioxidants and bacteria found in the tracheal mucosa, thereby accelerating aggregation, increasing colonization of microorganisms and forming biofilms on the surface of the cannula. The irritation by tracheostomy tube causes local inflammatory reaction and edema leading to bacterial colonization. To avoid the lower respiratory tract infection, careful hygiene of tracheostomy is recommended. Using sterile disposable suction catheters, gentle tracheal suction, bacteria free humidifiers, less visitors are recommended. However, despite of high level of hygiene, exogenous colonization with or without subsequent infection is common.

The outer cannula of tracheostomy tubes are routinely changed for a number of reasons. Regular tube changes are thought to aid in the prevention of stoma granulation tissue formation and tube blockage but are mainly done to reduce the rates of possible infection. Biofilm formation is a commonly cited reason for regular tracheostomy tube changes despite little supporting evidence, as they have are believed to cause deterioration in the tube surfaces. Inner cannulas of tracheostomy tubes act as liners and are changed on a daily or more often basis to prevent mucous build-up. A clinical consensus statement on tracheostomy care emphasized that effective wound care for tracheostomy patients has the positive effects of reducing the infection rate, shortening the time with a tracheal tube and improving patients' life quality. Gauze or moist dressings are widely used to take care of tracheostomy wounds.

Biofilm formation is a unique self-protective mechanism of bacteria, as it protects them from host immune response and antimicrobial agents. Biofilms are complex three dimensional structures, which are composed of bacteria, living in an extracellular matrix made of polysaccharides, nucleic acids and proteins. Studies showed that more than 60% of hospital acquired infections are caused by biofilm forming bacteria on medical devices. These infections are most commonly attributed to Staphylococcus aureus, Pseudomonas, and mixed flora.

Data regarding the colonization rates of tracheostomy tubes and the antimicrobial resistance and biofilm forming potential of bacteria colonizing tracheostomy tubes in Upper Egypt is still lacking.

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients (age > 16 years) from both sexes with tube in situ for more than 7 days at ENT department, Assiut University Hospital.

Description

Inclusion Criteria:

  • It includes tracheostomized adult patients (age > 16 years) from both sexes with tube in situ for more than 7 days.

Exclusion Criteria:

  • Patients will be excluded if they underwent an emergency tracheostomy tube change (i.e from dislodgement or obstruction), continue to require ongoing active machine ventilation, have an active lower respiratory tract infection or are immunosuppressed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of infection control program on reducing tracheostomy tube colonization with biofilm producing antimicrobial resistant bacteria
Time Frame: baseline

Assessment of infection control program performance among tracheostomized patients.

Identify the bacteria colonizing the tracheostomy tubes and their antibiotic resistance.

Recognize biofilm producing bacterial isolates. Characterize the exopolysaccharides encoding genes that correlate with bioflm formation.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Infection prevention & control

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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