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

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04681599
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 5
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 24, 2021
• Actual Primary Completion Date: Apr 13, 2021
• Actual Study Completion Date: Apr 13, 2021

Arms and Interventions

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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

• Principal Investigator: Jie Li, PhD, Rush University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT04681599
• Other Study ID Numbers: AGP aerosol 002
• First Posted: Dec 23, 2020
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Apr 22, 2021