Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

NCT04353531 | Completed

• 1 other identifier: COVID19-aerosol
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Transmission, Patient Professional; High-flow Nasal Cannula

Outcome Measures

Primary Outcomes (8)

• 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

Interventions

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.

Also known as: HFNC, high-flow high humidity nasal cannula

Surgical mask DEVICE

A procedure mask will be used to cover patient's face after HFNC is initiated.

Also known as: procedure mask

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests

You may not qualify if:

• No need for any respiratory therapy

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush university medical center

Chicago, Illinois, 60612, United States

Location

Related Publications (6)

• 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.

  PMID: 32129805 BACKGROUND

• 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.

  PMID: 30705129 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.

  PMID: 30336170 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.

  PMID: 23239991 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.

  PMID: 19522650 BACKGROUND

• 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.

  PMID: 33144080 DERIVED

MeSH Terms

Interventions

Intubation; Tracheostomy; Respiratory Function Tests

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Airway Management; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jie Li, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 20, 2020
• Study Start: May 20, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)