Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

NCT ID: NCT04353531

Last Updated: 2021-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Transmission, Patient Professional High-flow Nasal Cannula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Surgical mask

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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

Intervention Type DEVICE

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HFNC, high-flow high humidity nasal cannula procedure mask

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush university medical center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32129805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30705129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30336170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23239991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19522650 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33144080 (View on PubMed)

Other Identifiers

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COVID19-aerosol

Identifier Type: -

Identifier Source: org_study_id

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