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NCT Number: NCT04353531

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.

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Key information

Conditions

Transmission, Patient Professional High-flow Nasal Cannula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush university medical center

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Primary outcomes

  1. The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient

    Time frame: 5 minutes before procedure/treatment

    The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient's airway in the patient's room

  2. The virus load in the air sample pre procedure/treatment at 1 foot away from patient

    Time frame: 1 hour before procedure/treatment

    The virus load in the air sample pre procedure/treatment at 1 foot away from patient's airway in the patient's room

  3. The virus load in the air sample during/after procedure/treatment at 1 foot away from patient

    Time frame: 1 hour during/after procedure/treatment

    The virus load in the air sample during/after procedure/treatment at 1 foot away from patient's airway in the patient's room

  4. The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient

    Time frame: 5 minutes before procedure/treatment

    The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient's airway in the patient's room

  5. The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient

    Time frame: during procedure/treatment

    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

  6. The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patient

    Time frame: during procedure/treatment

    The aerosol mass/count concentration during procedure/ treatment at 3 feet away from HFNC in the patient's room

  7. The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient

    Time frame: 5 minutes post procedure/treatment

    The aerosol mass/count concentration post procedure/ treatment at 1 foot away from HFNC in the patient's room

  8. The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient

    Time frame: 5 minutes post procedure/treatment

    The aerosol mass/count concentration 5 mins procedure/ treatment at 3 feet away from HFNC in the patient's room

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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