Clinical trial NCT04353531: Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
Official title: An Observational Study to Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transmission, Patient Professional
High-flow Nasal Cannula
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient
timeFrame: 5 minutes before procedure/treatment
measure: The virus load in the air sample pre procedure/treatment at 1 foot away from patient
timeFrame: 1 hour before procedure/treatment
measure: The virus load in the air sample during/after procedure/treatment at 1 foot away from patient
timeFrame: 1 hour during/after procedure/treatment
measure: The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient
timeFrame: 5 minutes before procedure/treatment
measure: The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient
timeFrame: during procedure/treatment
measure: The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patient
timeFrame: during procedure/treatment
measure: The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient
timeFrame: 5 minutes post procedure/treatment
measure: The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient
timeFrame: 5 minutes post procedure/treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush university medical center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr.
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.
citation: 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.
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.
citation: 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.