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OpenTrials
Completed

NCT Number: NCT04681599

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

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.

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Key information

Conditions

Transmission, Patient-Professional

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Filter

Device

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

Scavenger face tent

Device

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

Primary outcomes

  1. aerosol particle concentrations at 1 foot away from subject's face

    Time frame: 5 mins

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

  2. aerosol particle concentrations at 3 feet away from subject's face

    Time frame: 5 mins

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

Secondary outcomes

  1. subject's comfort

    Time frame: 5 minutes after using the device

    subject's comfort will be self-evaluated using a visual numerical scale (VNS) ranging between 1 (very uncomfortable) and 5 (very comfortable)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Apr 22, 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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