Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

Study Overview
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Brief Summary
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Massive number of clinicians were infected during the outbreak of COVID-19, which raised the concerns of utilizing aerosol generating procedures, particularly the use of high-flow nasal cannula, noninvasive ventilation, intubation, bronchoscopy examination and pulmonary function test. There appears to be a trend to avoid those treatments. Instead, aggressive intubation might cause shortage of medical devices and add extra workload. Therefore, we aimed to do a clinical observational study to evaluate the aerosol generation in these procedures and explore the potential measures to reduce the aerosol generation or dispersion.

Detailed Description
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The intent is to monitor exhaled aerosol produced by COVID-19 patients pre and post aerosol generating procedures. Monitoring will occur at a distance of 1 and 3 feet from the subject's airway. This observational study will be conducted in standard patient hospital rooms (standard or negative pressure room).

Official Title
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An Observational Study to Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

Conditions
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Transmission, Patient Professional, High-flow Nasal Cannula

Intervention / Treatment
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* Device: High-flow nasal cannula
* Device: Surgical mask
* Procedure: bronchoscopy examination
* Procedure: intubation
* Procedure: tracheostomy
* Device: nebulization
* Diagnostic Test: Pulmonary function test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests Exclusion Criteria: • No need for any respiratory therapy

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: High-flow nasal cannula|High-flow nasal cannula is a modality of oxygen device that can provide gas flow meets or exceeds patient inspiratory flow demand (flow can be set at 10-60 L/min), it has been proven to improve oxygenation and reduce intubation rate in hypoxemic patients.|
|Device: Surgical mask|A procedure mask will be used to cover patient's face after HFNC is initiated.|
|Procedure: bronchoscopy examination|is a procedure that allows a doctor to examine the inside of the lungs, including the bronchi, which are the main pathways into the lungs. During a bronchoscopy, a doctor inserts a thin tube containing a light and camera into the lungs through the nose or mouth or via artificial airway such as intubation or tracheotomy tube|
|Procedure: intubation|Intubation is the process of inserting a tube, called an endotracheal tube (ET), through the mouth and then into the airway. This is done so that a patient can be placed on a ventilator to assist with breathing during anesthesia, sedation, or severe illness.|
|Procedure: tracheostomy|A tracheostomy is a medical procedure - either temporary or permanent - that involves creating an opening in the neck in order to place a tube into a person's windpipe. The tube is inserted through a cut in the neck below the vocal cords. This allows air to enter the lungs.|
|Device: nebulization|A nebulizer is a piece of medical equipment that a person with asthma or another respiratory condition can use to administer medication directly and quickly to the lungs|
|Diagnostic Test: Pulmonary function test|Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient | The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient's airway in the patient's room | 5 minutes before procedure/treatment | 
| The virus load in the air sample pre procedure/treatment at 1 foot away from patient | The virus load in the air sample pre procedure/treatment at 1 foot away from patient's airway in the patient's room | 1 hour before procedure/treatment | 
| The virus load in the air sample during/after procedure/treatment at 1 foot away from patient | The virus load in the air sample during/after procedure/treatment at 1 foot away from patient's airway in the patient's room | 1 hour during/after procedure/treatment | 
| The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient | The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient's airway in the patient's room | 5 minutes before procedure/treatment | 
| The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient | The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient's airway in the patient's room | during procedure/treatment | 
| The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patient | The aerosol mass/count concentration during procedure/ treatment at 3 feet away from HFNC in the patient's room | during procedure/treatment | 
| The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient | The aerosol mass/count concentration post procedure/ treatment at 1 foot away from HFNC in the patient's room | 5 minutes post procedure/treatment | 
| The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient | The aerosol mass/count concentration 5 mins procedure/ treatment at 3 feet away from HFNC in the patient's room | 5 minutes post procedure/treatment |