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Tracheostomy InfectionNCT05113329

Infection Control Program in Tracheostomized Patients

An observational study of Tracheostomy Infection, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Tracheostomy Infection
How many people
52 participants
Where
No sites listed yet
Study dates
1 Jun 2022to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Hanaa Aref, Master contact

+201002612727

hanaa.aref@gmail.com

About this study

Official title: 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.

Read more

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of infection control program on reducing tracheostomy tube colonization with biofilm producing antimicrobial resistant bacteria

    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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05113329
Sponsor's protocol ID
Infection prevention & control
Status last verified
Mar 2022
First submitted
18 Oct 2021
Last updated
3 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mathur T, Singhal S, Khan S, Upadhyay DJ, Fatma T, Rattan A. Detection of biofilm formation among the clinical isolates of Staphylococci: an evaluation of three different screening methods. Indian J Med Microbiol. 2006 Jan;24(1):25-9. doi: 10.4103/0255-0857.19890.

    PubMed 16505551
  • Kamali E, Jamali A, Ardebili A, Ezadi F, Mohebbi A. Evaluation of antimicrobial resistance, biofilm forming potential, and the presence of biofilm-related genes among clinical isolates of Pseudomonas aeruginosa. BMC Res Notes. 2020 Jan 10;13(1):27. doi: 10.1186/s13104-020-4890-z.

    PubMed 31924268
  • Miari M, Rasheed SS, Haidar Ahmad N, Itani D, Abou Fayad A, Matar GM. Natural products and polysorbates: Potential Inhibitors of biofilm formation in Pseudomonas aeruginosa. J Infect Dev Ctries. 2020 Jun 30;14(6):580-588. doi: 10.3855/jidc.11834.

    PubMed 32683348
  • Bogiel T, Depka D, Rzepka M, Kwiecinska-Pirog J, Gospodarek-Komkowska E. Prevalence of the Genes Associated with Biofilm and Toxins Synthesis amongst the Pseudomonas aeruginosa Clinical Strains. Antibiotics (Basel). 2021 Feb 28;10(3):241. doi: 10.3390/antibiotics10030241.

    PubMed 33670887
  • Heffner JE, Hess D. Tracheostomy management in the chronically ventilated patient. Clin Chest Med. 2001 Mar;22(1):55-69. doi: 10.1016/s0272-5231(05)70025-3.

    PubMed 11315459
  • Raveendra N, Rathnakara SH, Haswani N, Subramaniam V. Bacterial Biofilms on Tracheostomy Tubes. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):4995-4999. doi: 10.1007/s12070-021-02598-6. Epub 2021 May 6.

    PubMed 33972925
  • Hutauruk SM, Hermani B, Monasari P. Role of chlorhexidine on tracheostomy cannula decontamination in relation to the growth of Biofilm-Forming Bacteria Colony- a randomized controlled trial study. Ann Med Surg (Lond). 2021 Jun 10;67:102491. doi: 10.1016/j.amsu.2021.102491. eCollection 2021 Jul.

    PubMed 34194732
  • Tan CY, Chiu NC, Lee KS, Chi H, Huang FY, Huang DT, Chang L, Kung YH, Huang CY. Respiratory tract infections in children with tracheostomy. J Microbiol Immunol Infect. 2020 Apr;53(2):315-320. doi: 10.1016/j.jmii.2018.07.002. Epub 2018 Aug 9.

    PubMed 30131258
  • Kumarasinghe D, Wong EH, Duvnjak M, Smith MC, Palme CE, Riffat F. Colonization rates of tracheostomy tubes associated with the frequency of tube changes. ANZ J Surg. 2020 Nov;90(11):2310-2314. doi: 10.1111/ans.15970. Epub 2020 May 17.

    PubMed 32419324
  • Bontempo LJ, Manning SL. Tracheostomy Emergencies. Emerg Med Clin North Am. 2019 Feb;37(1):109-119. doi: 10.1016/j.emc.2018.09.010.

    PubMed 30454773

Questions about this trial

What is this clinical trial studying?

An observational study of Tracheostomy Infection, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hanaa Aref, Master (+201002612727, hanaa.aref@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of infection control program on reducing tracheostomy tube colonization with biofilm producing antimicrobial resistant bacteria (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05113329, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.

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