Infection Control Program in Tracheostomized Patients

NCT05113329 | Unknown

• 1 other identifier: Infection prevention & control
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Tracheostomy Infection

Outcome Measures

Primary Outcomes (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.

  baseline

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 16505551 BACKGROUND

• 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.

  PMID: 31924268 BACKGROUND

• 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.

  PMID: 32683348 BACKGROUND

• 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.

  PMID: 33670887 BACKGROUND

• 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.

  PMID: 11315459 BACKGROUND

• 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.

  PMID: 33972925 BACKGROUND

• 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.

  PMID: 34194732 BACKGROUND

• 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.

  PMID: 30131258 BACKGROUND

• 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.

  PMID: 32419324 BACKGROUND

• 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.

  PMID: 30454773 BACKGROUND

Central Study Contacts

Hanaa Aref, Master

CONTACT

+201002612727; hanaa.aref@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 9, 2021
• Study Start: June 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-03