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

Not Applicable

Completed

• Conditions: Transmission, Patient-Professional
• Interventions: Device: Filter; Device: Scavenger face tent

• Registration Number: NCT04681599
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-01-24
• Status Verified: 2021-04
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebulization with a filter or scavenger	Scavenger face tent	Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask
Nebulization with a filter or scavenger	Filter	Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask
High-flow nasal cannula with a scavenger face tent	Scavenger face tent	Subject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent
High-flow nasal cannula with a surgical mask	Filter	Subject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States