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Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers

Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04681599
Enrollment
18
Registered
2020-12-23
Start date
2021-01-24
Completion date
2021-04-13
Last updated
2021-04-22

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

Conditions

Transmission, Patient-Professional

Keywords

aerosol generating procedure, high-flow nasal cannula, nebulization, aerosol therapy

Brief summary

Several clinical procedures have been described as aerosol generating procedure (AGP), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. However, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. This study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.

Interventions

DEVICEFilter

Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases

DEVICEScavenger face tent

A face tent is connected to a vacuum resource to continuously suction the exhaled gas from the subject, in order to reduce the transmission risk of virus or bacteria

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

• Ages 18-65, Male or Female

Exclusion criteria

* Chronic lung disease, including asthma, COPD, etc. * Upper airway anatomical abnormities * Pregnancy * Uncontrolled Diabetes, hypertension, or untreated thyroid disease * Has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit. * COVID-19 test positive within 21 days.

Design outcomes

Primary

MeasureTime frameDescription
aerosol particle concentrations at 1 foot away from subject's face5 minsaerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 1 foot away from subject's face
aerosol particle concentrations at 3 feet away from subject's face5 minsaerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 3 feet away from subject's face

Secondary

MeasureTime frameDescription
subject's comfort5 minutes after using the devicesubject's comfort will be self-evaluated using a visual numerical scale (VNS) ranging between 1 (very uncomfortable) and 5 (very comfortable)

Countries

United States

Outcome results

None listed

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