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

Transmission, Patient-Professional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681599
• Other study ID #: AGP aerosol 002
• Status: Completed
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: April 13, 2021

Study information

• Verified date: April 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transmission, Patient-Professional

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Dhand R, Li J. Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2. Am J Respir Crit Care Med. 2020 Sep 1;202(5):651-659. doi: 10.1164/rccm.202004-1263PP. Review. — View Citation

Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C, Martin AR, Rothen-Rutishauser B, Kuehl PJ, Häussermann S, MacLoughlin R, Smaldone GC, Muellinger B, Corcoran TE, Dhand R. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: A — View Citation

Kaur R, Weiss TT, Perez A, Fink JB, Chen R, Luo F, Liang Z, Mirza S, Li J. Practical strategies to reduce nosocomial transmission to healthcare professionals providing respiratory care to patients with COVID-19. Crit Care. 2020 Sep 23;24(1):571. doi: 10.1 — View Citation

Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5). pii: 2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aerosol particle concentrations at 1 foot away from subject's face	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
Primary	aerosol particle concentrations at 3 feet away from subject's face	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	subject's comfort	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