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Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04353531
Enrollment
15
Registered
2020-04-20
Start date
2020-05-20
Completion date
2020-08-30
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-flow Nasal Cannula, Transmission, Patient Professional

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).

Interventions

DEVICEHigh-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.

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

PROCEDUREbronchoscopy 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

PROCEDUREintubation

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.

PROCEDUREtracheostomy

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.

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

DIAGNOSTIC_TESTPulmonary 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.

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient5 minutes before procedure/treatmentThe aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient's airway in the patient's room
The virus load in the air sample pre procedure/treatment at 1 foot away from patient1 hour before procedure/treatmentThe virus load in the air sample pre procedure/treatment at 1 foot away from patient's airway in the patient's room
The virus load in the air sample during/after procedure/treatment at 1 foot away from patient1 hour during/after procedure/treatmentThe virus load in the air sample during/after procedure/treatment at 1 foot away from patient's airway in the patient's room
The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient5 minutes before procedure/treatmentThe aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient's airway in the patient's room
The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patientduring procedure/treatmentThe 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
The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patientduring procedure/treatmentThe aerosol mass/count concentration during procedure/ treatment at 3 feet away from HFNC in the patient's room
The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient5 minutes post procedure/treatmentThe aerosol mass/count concentration post procedure/ treatment at 1 foot away from HFNC in the patient's room
The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient5 minutes post procedure/treatmentThe aerosol mass/count concentration 5 mins procedure/ treatment at 3 feet away from HFNC in the patient's room

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026