- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565405
Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas
Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seok Hwee Koo, PhD
- Phone Number: 68504929
- Email: seok_hwee_koo@cgh.com.sg
Study Locations
-
-
-
Singapore, Singapore, 529889
- Recruiting
- Clinical Trials & Research Unit
-
Contact:
- Lay Hwa Yew
- Phone Number: 65-68502375
- Email: yew.lay.hwa@singhealth.com.sg
-
Sub-Investigator:
- Rajkumar Chandran
-
Sub-Investigator:
- Peter Lu
-
Sub-Investigator:
- Alvin Tan
-
Sub-Investigator:
- Si Huei Tan
-
Sub-Investigator:
- Siew Yong Ng
-
Sub-Investigator:
- Soon Keow Neo
-
Sub-Investigator:
- Jia Yan Lim
-
Sub-Investigator:
- Qiu Sha Meng
-
Sub-Investigator:
- Fazlina Bte Abdul Hathi
-
Sub-Investigator:
- Liping Zhao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AB (Detergent (A) followed by sterile water (B))
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. |
The tracheostomy inner cannulas will be washed with detergent.
The tracheostomy inner cannulas will be washed with sterile water.
|
Experimental: BA (Sterile water (B) followed by detergent (A))
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. |
The tracheostomy inner cannulas will be washed with detergent.
The tracheostomy inner cannulas will be washed with sterile water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Economic evaluation
Time Frame: 2 years
|
Compare the expenses incurred from cleaning the inner cannulas using water vs detergent
|
2 years
|
Microbiological evaluation
Time Frame: 2 weeks
|
Compare the profile of bacteria identified from a proportion of samples sent for bacterial culture between the water and detergent groups
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hong Eng Chan, Changi General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Inner Cannula
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tracheostomy Complication
-
Instituto de Investigación Hospital Universitario...RecruitingTracheostomy ComplicationSpain
-
Rush University Medical CenterWithdrawnTracheostomy ComplicationUnited States
-
Ohio State UniversityWithdrawnTracheostomy ComplicationUnited States
-
Melike CengizCompletedTracheostomy ComplicationTurkey
-
Diskapi Yildirim Beyazit Education and Research...CompletedTracheostomy Complication | Percutaneous Tracheostomy | High-frequency Jet VentilationTurkey
-
Rigshospitalet, DenmarkRecruitingTracheostomy ComplicationDenmark
-
HULYA TOPCUSerhat OzciftciCompletedTracheostomy ComplicationTurkey
-
The First Affiliated Hospital of Shanxi Medical...Completed
-
Assiut UniversityCompletedTracheostomy ComplicationEgypt
-
Hadassah Medical OrganizationUnknownOther Tracheostomy Complication
Clinical Trials on Detergent
-
OctapharmaTerminatedThrombotic Thrombocytopenic Purpura (TTP)United States
-
Baxter Healthcare CorporationCompletedHip Replacement SurgeryAustria, Germany, Netherlands
-
St. Olavs HospitalNorwegian University of Science and TechnologyWithdrawnPurpura, Thrombotic Thrombocytopenic
-
Baxter Healthcare CorporationCompletedCardiopulmonary Bypass | Sternotomy | Cardiac Surgery Requiring Cardiopulmonary Bypass and Median SternotomyUnited States
-
Baxter Healthcare CorporationCompletedAdjunct to Hemostasis During Vascular SurgeryRussian Federation
-
Baxalta now part of ShireCompletedPrimary Immunodeficiency Diseases (PID) | Hypogammaglobulinemia | AgammaglobulinemiaFinland, Sweden
-
Theodor Bilharz Research InstituteActive, not recruitingUrinary Bladder Neoplasms | MicrotiaEgypt
-
Baxter Healthcare CorporationCompletedSinus Implant ReconstructionGermany
-
Baxter Healthcare CorporationCompletedFacial Rhytidectomy (Face-lift)United States
-
Baxter Healthcare CorporationCompletedHemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft ProsthesesUnited States