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

NCT04681599 | Completed

• 1 other identifier: AGP aerosol 002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Transmission, Patient-Professional

Keywords

aerosol generating procedure; high-flow nasal cannula; nebulization; aerosol therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• subject's comfort

  5 minutes after using the device

Study Arms (5)

Nebulization without filter or scavenger

NO INTERVENTION

Subject will use a standard nebulizer

Nebulization with a filter or scavenger

EXPERIMENTAL

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; Device: Scavenger face tent

High-flow nasal cannula

NO INTERVENTION

Subject will use high-flow nasal cannula at 40 L/min

High-flow nasal cannula with a scavenger face tent

EXPERIMENTAL

Subject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent

Device: Scavenger face tent

High-flow nasal cannula with a surgical mask

ACTIVE COMPARATOR

Subject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula

Device: Filter

Interventions

Filter DEVICE

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

High-flow nasal cannula with a surgical mask; Nebulization with a filter or scavenger

Scavenger face tent DEVICE

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

High-flow nasal cannula with a scavenger face tent; Nebulization with a filter or scavenger

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65, Male or Female

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related 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. No abstract available.

  PMID: 32543913 RESULT

• 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):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May.

  PMID: 32299867 RESULT

• Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C, Martin AR, Rothen-Rutishauser B, Kuehl PJ, Haussermann S, MacLoughlin R, Smaldone GC, Muellinger B, Corcoran TE, Dhand R. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine. J Aerosol Med Pulm Drug Deliv. 2020 Dec;33(6):300-304. doi: 10.1089/jamp.2020.1615. Epub 2020 Aug 12.

  PMID: 32783675 RESULT

• 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: 10.1186/s13054-020-03231-8.

  PMID: 32967700 RESULT

Study Officials

• Jie Li, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: January 24, 2021
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)