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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula | Device | 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. |
| |
| Surgical mask | Device | A procedure mask will be used to cover patient's face after HFNC is initiated. |
| |
| bronchoscopy examination | Procedure | 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 | ||
| intubation | Procedure | 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. |
| 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 |
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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
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Adult patients who are diagnosed as COVID-19 infection and admitted to adult ICU will be enrolled in Rush University Medical Center, Chicago, IL, USA. Patients will be excluded if patients do not require any respiratory treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Jie Li, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush university medical center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32129805 | Background | Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227. | |
| 30705129 | Background |
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De-identified data may be shared for research purpose based on request
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| tracheostomy | Procedure | 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. |
| nebulization | Device | 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 |
| Pulmonary function test | Diagnostic 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. |
| 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 |
| Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr. |
| 30336170 | Background | Leung CCH, Joynt GM, Gomersall CD, Wong WT, Lee A, Ling L, Chan PKS, Lui PCW, Tsoi PCY, Ling CM, Hui M. Comparison of high-flow nasal cannula versus oxygen face mask for environmental bacterial contamination in critically ill pneumonia patients: a randomized controlled crossover trial. J Hosp Infect. 2019 Jan;101(1):84-87. doi: 10.1016/j.jhin.2018.10.007. Epub 2018 Oct 15. |
| 23239991 | Background | Hui DS, Chow BK, Chu L, Ng SS, Lee N, Gin T, Chan MT. Exhaled air dispersion during coughing with and without wearing a surgical or N95 mask. PLoS One. 2012;7(12):e50845. doi: 10.1371/journal.pone.0050845. Epub 2012 Dec 5. |
| 19522650 | Background | Johnson DF, Druce JD, Birch C, Grayson ML. A quantitative assessment of the efficacy of surgical and N95 masks to filter influenza virus in patients with acute influenza infection. Clin Infect Dis. 2009 Jul 15;49(2):275-7. doi: 10.1086/600041. |
| 33144080 | Derived | Li J, Jing G, Fink JB, Porszasz J, Moran EM, Kiourkas RD, McLaughlin R, Vines DL, Dhand R. Airborne Particulate Concentrations During and After Pulmonary Function Testing. Chest. 2021 Apr;159(4):1570-1574. doi: 10.1016/j.chest.2020.10.064. Epub 2020 Nov 1. No abstract available. |
| ID | Term |
|---|---|
| D007440 | Intubation |
| D014139 | Tracheostomy |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D058109 | Airway Management |
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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