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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681599
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transmission, Patient-Professional Device: Filter Device: Scavenger face tent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial
Actual Study Start Date : January 24, 2021
Actual Primary Completion Date : April 13, 2021
Actual Study Completion Date : April 13, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681599


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Jie Li, PhD Rush University
More Information
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Publications of Results:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04681599    
Other Study ID Numbers: AGP aerosol 002
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data would not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
aerosol generating procedure
high-flow nasal cannula
nebulization
aerosol therapy