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

NCT ID: NCT04681599

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-24

Study Completion Date

2021-04-13

Brief Summary

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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

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Conditions

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Transmission, Patient-Professional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nebulization without filter or scavenger

Subject will use a standard nebulizer

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Filter

Intervention Type DEVICE

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

Scavenger face tent

Intervention Type 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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Scavenger face tent

Intervention Type 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 surgical mask

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

Group Type ACTIVE_COMPARATOR

Filter

Intervention Type DEVICE

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

Interventions

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Filter

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 32543913 (View on PubMed)

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.

Reference Type RESULT
PMID: 32299867 (View on PubMed)

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.

Reference Type RESULT
PMID: 32783675 (View on PubMed)

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.

Reference Type RESULT
PMID: 32967700 (View on PubMed)

Other Identifiers

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AGP aerosol 002

Identifier Type: -

Identifier Source: org_study_id

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