Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

High-flow Nasal Cannula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353531
• Other study ID #: COVID19-aerosol
• Status: Completed
• Start date: May 20, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: April 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High-flow Nasal Cannula
• Transmission, Patient Professional

Intervention

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.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rush university medical center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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). pii: 1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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