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

• ClinicalTrials.gov Identifier: NCT04681599
• Recruitment Status: Completed
• First Posted: December 23, 2020
• Last Update Posted: April 22, 2021
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Rush University Medical Center

Tracking Information

• First Submitted Date: December 18, 2020
• First Posted Date: December 23, 2020
• Last Update Posted Date: April 22, 2021
• Actual Study Start Date: January 24, 2021
• Actual Primary Completion Date: April 13, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2020)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 23, 2020)

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)

Original Secondary Outcome Measures (submitted: December 18, 2020)

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 to 5

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers
• Official Title: Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other
• Condition: 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
• 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

Study Arms

• 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
  Interventions:

  • Device: Filter
  • Device: Scavenger face tent
• 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
  Intervention: Device: Scavenger face tent
• 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
  Intervention: Device: Filter

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2020): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 13, 2021
• Actual Primary Completion Date: April 13, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04681599
• Other Study ID Numbers: AGP aerosol 002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: individual participant data would not be shared

• Current Responsible Party: Rush University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Rush University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jie Li, PhD; Rush University

• PRS Account: Rush University Medical Center
• Verification Date: April 2021