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

April 21, 2021 updated by: Rush University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Nebulization without filter or scavenger
Subject will use a standard nebulizer
Experimental: Nebulization with a filter or scavenger
Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask
Device: Filter
Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases
Device: Scavenger 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
No Intervention: High-flow nasal cannula
Subject will use high-flow nasal cannula at 40 L/min
Experimental: High-flow nasal cannula with a scavenger face tent
Subject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent
Device: Scavenger 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
Active Comparator: High-flow nasal cannula with a surgical mask
Subject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula
Device: Filter
Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 mins
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
5 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 minutes after using the device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2021

Primary Completion (Actual)

April 13, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AGP aerosol 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data would not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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