Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas

NCT04565405 | Unknown

• 1 other identifier: Inner Cannula
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Biofilms pose a potential risk with reusable inner cannulas, by increasing the risk of infection. Effective decontamination is vital in eliminating these biofilms. An appropriate method of cleaning and decontamination to make inner cannula safe for reuse should be practiced. The current recommendations for cleaning inner cannula are varied with multiple techniques being put forth. The current practice of using sterile water to clean inner cannula is not supported by strong evidence. This Randomized Controlled Study looks into the microbiological efficacy of sterile water in cleaning inner cannulas.

Conditions

Tracheostomy Complication

Keywords

Tracheostomy; Inner cannulas; Decontamination; Microbiological evaluation

Outcome Measures

Primary Outcomes (1)

• Efficacy of water vs detergent in cleaning tracheostomy inner cannulas

  Compare the colony forming units / ml before and after cleaning with water vs detergent

  1 week

Secondary Outcomes (2)

• Economic evaluation

  2 years

• Microbiological evaluation

  2 weeks

Study Arms (2)

AB (Detergent (A) followed by sterile water (B))

EXPERIMENTAL

Sequence: Detergent (A) followed by sterile water (B) The inner cannula will be cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK) in the first visit, and then cleaned with sterile water in the second visit, at a minimum period of 24 hrs apart. Laboratory analysis of colony counts will be conducted on the saline flushing pre- and post-decontamination for each washing.

Other: Detergent; Other: Sterile water

BA (Sterile water (B) followed by detergent (A))

EXPERIMENTAL

Sequence: Sterile water (B) followed by detergent (A) The inner cannula will be cleaned with sterile water in the first visit, and then cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK) in the second visit, at a minimum period of 24 hrs apart. Laboratory analysis of colony counts will be conducted on the saline flushing pre- and post-decontamination for each washing.

Other: Detergent; Other: Sterile water

Interventions

Detergent OTHER

The tracheostomy inner cannulas will be washed with detergent.

AB (Detergent (A) followed by sterile water (B)); BA (Sterile water (B) followed by detergent (A))

Sterile water OTHER

The tracheostomy inner cannulas will be washed with sterile water.

AB (Detergent (A) followed by sterile water (B)); BA (Sterile water (B) followed by detergent (A))

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 21 - 100 years
• Patients with a tracheostomy tube in situ

You may not qualify if:

• Pregnant women
• Prisoners
• Patients with documented HIV, Hep C, Hep B
• Patients with active tuberculosis
• Patients being treated in Intensive Care Units
• Patients with ongoing antibiotic treatment or within the last 24 hours
• Unstable patients needing cardiorespiratory support

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Clinical Trials & Research Unit

Singapore, 529889, Singapore

RECRUITING

Related Publications (1)

• Bjorling G, Belin AL, Hellstrom C, Schedin U, Ransjo U, Alenius M, Johansson UB. Tracheostomy inner cannula care: a randomized crossover study of two decontamination procedures. Am J Infect Control. 2007 Nov;35(9):600-5. doi: 10.1016/j.ajic.2006.11.006.

  PMID: 17980239 BACKGROUND

MeSH Terms

Interventions

Detergents

Intervention Hierarchy (Ancestors)

Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Hong Eng Chan

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Hwee Koo, PhD

CONTACT

68504929; seok_hwee_koo@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible patients will be randomized in 1:1 fashion using permuted blocks with different block sizes. The subjects and lab operators will be blinded to the block size and randomization. In the event unmasking need to be performed, a staff who is not involved in this study from Clinical Trial Unit will perform the unmasking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Nurse Clinician

Model Details: This is a single centre, single blinded, randomized cross over study comparing two decontamination procedures Detergent (A) and Sterile water (B) on inner cannulas. To avoid the influence of confounding covariates, we propose to have a cross over study. The cross over patient will act as his own control. The selected patients will be randomly allocated to sequence AB or BA in 1:1 fashion using permuted blocks with different block sizes. The change of sequence A \> B and B \> A will take place only after minimum of 24 hours after the first part of sequence has been completed.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 25, 2020
• Study Start: March 30, 2017
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)