Tracheostomy ComplicationNCT04565405
Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas
A study testing Detergent and Sterile water in people with Tracheostomy Complication, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- Detergent and Sterile water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Mar 2017to 16 Nov 2020
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients under the purview of the tracheostomy care team at Changi General Hospital will be considered for inclusion in the study.
- Patients aged between 21 - 100 years
- Patients with a tracheostomy tube in situ
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Clinical Trials & Research Unit
Singapore, 529889
Lay Hwa Yew, 65-68502375, yew.lay.hwa@singhealth.com.sg
Rajkumar Chandran
About this study
Official title: Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas: A Randomized Control Trial
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.
Read the detailed description
Tracheostomy Care of Patients:
The tracheostomy care of all patients included in the study will be the same as any other tracheostomy patient in the hospital, as directed by the tracheostomy care nursing policy. Before study procedure, inner cannula is to be checked to ensure it is not clogged with secretion, any secretion is to be removed with suction.
Decontamination methods:
Patients may fall under group A or group B as determined by the random allocation.
Patients in decontamination group A: Detergent
Pre Decontamination:
- The inner cannula care will be removed using aseptic precautions.
- 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
- Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Decontamination:
- Inner cannula will be cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK).
- The cleaning is done as per manufacturers recommendation.
Post Decontamination:
- Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
Patients in decontamination group B: Water
Pre Decontamination:
- The inner cannula care will be removed using aseptic precautions.
- 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
- Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Decontamination:
- Inner cannula is cleaned as per the current tracheostomy care guidelines as directed by the Nursing Policy for Tracheostomy Care, Changi General Hospital. Only Sterile water is recommended as per the policy.
Post Decontamination:
- Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
Crossover of Patients:
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 subjects and lab operators will be blinded to the block size and randomization.
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. Exclusion criteria will still be applicable after completion of one part of the sequence. Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Lab Method for Colony Counts:
From the flush solution, 100 microlitres and further sequential serial dilutions of 1:10 (in saline) are cultured directly onto blood agar plates. After 72 hours aerobic incubation at 35oC, all plates are examined and growth from plates with 10 to 100 colonies per plate are counted. Total bacterial growth will be expressed as colony-forming unit (cfu)/ml.
Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
- Conditions
- Tracheostomy Complication
- Being tested
- Detergent, Sterile water
- Keywords
- Tracheostomy, Inner cannulas, Decontamination, Microbiological evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetergentOther
The tracheostomy inner cannulas will be washed with detergent.
Sterile waterOther
The tracheostomy inner cannulas will be washed with sterile water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Detergent; Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of water vs detergent in cleaning tracheostomy inner cannulas
Compare the colony forming units / ml before and after cleaning with water vs detergent
Measured: 1 week
Secondary outcomes (2)
Economic evaluation
Compare the expenses incurred from cleaning the inner cannulas using water vs detergent
Measured: 2 years
Microbiological evaluation
Compare the profile of bacteria identified from a proportion of samples sent for bacterial culture between the water and detergent groups
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start30 Mar 2017
- Primary completion16 Nov 2020 (estimated)
- Study completion16 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Hong Eng, Changi General Hospital
- Investigators
- Hong Eng Chan, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565405
- Sponsor's protocol ID
- Inner Cannula
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17980239
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04565405
- Acronym / sponsor ID
- Inner Cannula
- Conditions
- Tracheostomy Complication
- Keywords
- Tracheostomy, Inner cannulas, Decontamination, Microbiological evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 16 Nov 2020 (estimated)
- Study completion
- 16 Nov 2020 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tracheostomy Care of Patients:
The tracheostomy care of all patients included in the study will be the same as any other tracheostomy patient in the hospital, as directed by the tracheostomy care nursing policy. Before study procedure, inner cannula is to be checked to ensure it is not clogged with secretion, any secretion is to be removed with suction.
Decontamination methods:
Patients may fall under group A or group B as determined by the random allocation.
Patients in decontamination group A: Detergent
Pre Decontamination:
- The inner cannula care will be removed using aseptic precautions.
- 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
- Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Decontamination:
- Inner cannula will be cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK).
- The cleaning is done as per manufacturers recommendation.
Post Decontamination:
- Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
Patients in decontamination group B: Water
Pre Decontamination:
- The inner cannula care will be removed using aseptic precautions.
- 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
- Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Decontamination:
- Inner cannula is cleaned as per the current tracheostomy care guidelines as directed by the Nursing Policy for Tracheostomy Care, Changi General Hospital. Only Sterile water is recommended as per the policy.
Post Decontamination:
- Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.
- The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.
Crossover of Patients:
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 subjects and lab operators will be blinded to the block size and randomization.
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. Exclusion criteria will still be applicable after completion of one part of the sequence. Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Lab Method for Colony Counts:
From the flush solution, 100 microlitres and further sequential serial dilutions of 1:10 (in saline) are cultured directly onto blood agar plates. After 72 hours aerobic incubation at 35oC, all plates are examined and growth from plates with 10 to 100 colonies per plate are counted. Total bacterial growth will be expressed as colony-forming unit (cfu)/ml.
Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AB (Detergent (A) followed by sterile water (B)) | Experimental | Other: Detergent, Other: Sterile waterSequence: 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. |
| BA (Sterile water (B) followed by detergent (A)) | Experimental | Other: Detergent, Other: Sterile waterSequence: 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients under the purview of the tracheostomy care team at Changi General Hospital will be considered for inclusion in the study.
- Patients aged between 21 - 100 years
- Patients with a tracheostomy tube in situ
Key exclusion criteria (7 listed)
- Pregnant women
- Prisoners
- Patients with documented HIV, Hep C, Hep B
- Patients with active tuberculosis
- Patients being treated in Intensive Care Units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DetergentThe tracheostomy inner cannulas will be washed with detergent. | Other | AB (Detergent (A) followed by sterile water (B)), BA (Sterile water (B) followed by detergent (A)) |
| Sterile waterThe tracheostomy inner cannulas will be washed with sterile water. | Other | AB (Detergent (A) followed by sterile water (B)), BA (Sterile water (B) followed by detergent (A)) |
Primary outcome
Efficacy of water vs detergent in cleaning tracheostomy inner cannulas
Time frame: 1 week
Compare the colony forming units / ml before and after cleaning with water vs detergent
2 secondary outcomes
Economic evaluation
Time frame: 2 years
Microbiological evaluation
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 17980239Bjorling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Eng Chan principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detergent and Sterile water in people with Tracheostomy Complication, run by Changi General Hospital at 1 site in Singapore.
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 3 inclusion and 7 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Seok Hwee Koo, PhD (68504929, seok_hwee_koo@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of water vs detergent in cleaning tracheostomy inner cannulas (time frame: 1 week). 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 NCT04565405, which also lists 1 linked publication.
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 25 Sep 2020.