Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

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

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.

Study Overview

• Status: Completed
• Conditions: High-flow Nasal Cannula; Transmission, Patient Professional
• Intervention / Treatment: Device: High-flow nasal cannula; Device: Surgical mask; Procedure: bronchoscopy examination; Procedure: intubation; Procedure: tracheostomy; Device: nebulization; Diagnostic test: Pulmonary function test

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Jie Li, PhD, Rush University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: COVID19-aerosol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data may be shared for research purpose based on request