Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers

Study Overview
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Brief Summary
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Several clinical procedures have been described as aerosol generating procedure (AGP), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. However, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. This study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.

Official Title
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Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial

Conditions
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Transmission, Patient-Professional

Intervention / Treatment
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* Device: Filter
* Device: Scavenger face tent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Ages 18-65, Male or Female Exclusion Criteria: Chronic lung disease, including asthma, COPD, etc. Upper airway anatomical abnormities Pregnancy Uncontrolled Diabetes, hypertension, or untreated thyroid disease Has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit. COVID-19 test positive within 21 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nebulization without filter or scavenger<br>Subject will use a standard nebulizer | |
| Experimental: Nebulization with a filter or scavenger<br>Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask | Device: Filter<br>* Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases<br>Device: Scavenger face tent<br>* A face tent is connected to a vacuum resource to continuously suction the exhaled gas from the subject, in order to reduce the transmission risk of virus or bacteria<br>|
| No Intervention: High-flow nasal cannula<br>Subject will use high-flow nasal cannula at 40 L/min | |
| Experimental: High-flow nasal cannula with a scavenger face tent<br>Subject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent | Device: Scavenger face tent<br>* A face tent is connected to a vacuum resource to continuously suction the exhaled gas from the subject, in order to reduce the transmission risk of virus or bacteria<br>|
| Active Comparator: High-flow nasal cannula with a surgical mask<br>Subject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula | Device: Filter<br>* Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aerosol particle concentrations at 1 foot away from subject's face | aerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 1 foot away from subject's face | 5 mins | 
| aerosol particle concentrations at 3 feet away from subject's face | aerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 3 feet away from subject's face | 5 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject's comfort | subject's comfort will be self-evaluated using a visual numerical scale (VNS) ranging between 1 (very uncomfortable) and 5 (very comfortable) | 5 minutes after using the device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerosol generating procedure, high-flow nasal cannula, nebulization, aerosol therapy