Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device

Study Overview
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Brief Summary
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This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant

Detailed Description
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There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination. This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave. The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.

Official Title
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Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial

Conditions
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Sterility

Intervention / Treatment
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* Device: Novel rig-S
* Device: Conventional Autoclave machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All rigid endoscopes performed in ORL clinic Exclusion Criteria: Flexible endoscopes performed in ORL clinic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Autoclave<br>The conventional autoclave is the gold standard of sterilising all medical equipments. | Device: Novel rig-S<br>* A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed<br>Device: Conventional Autoclave machine<br>* The gold standard device to clean all medical instruments<br>|
| Active Comparator: Novel rig-S<br>A novel devise used with the high level disinfectant | Device: Novel rig-S<br>* A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed<br>Device: Conventional Autoclave machine<br>* The gold standard device to clean all medical instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial and Hepatitis B test | Rigid endoscopes are swabbed and tested using a hep-B kit | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acidity level | Acidity level of the high level disinfectant is tested for every 10 cycles of scope | 4 hours |