Transmission, Patient-ProfessionalNCT04681599
Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers
A study testing Filter and Scavenger face tent in people with Transmission, Patient-Professional, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transmission, Patient-Professional
- What is being tested?
- Filter and Scavenger face tent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2021to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-65, Male or Female
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial
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
- Being tested
- Filter, Scavenger face tent
- Keywords
- aerosol generating procedure, high-flow nasal cannula, nebulization, aerosol therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilterDevice
Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases
Scavenger face tentDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 mins
Secondary outcomes (1)
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)
Measured: 5 minutes after using the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start24 Jan 2021
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transmission, Patient-ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Li, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681599
- Sponsor's protocol ID
- AGP aerosol 002
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2020
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data would not be shared
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.
PubMed 32543913Li 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.
PubMed 32299867Fink 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.
PubMed 32783675Kaur 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.
PubMed 32967700
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT04681599
- Acronym / sponsor ID
- AGP aerosol 002
- Conditions
- Transmission, Patient-Professional
- Keywords
- aerosol generating procedure, high-flow nasal cannula, nebulization, aerosol therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nebulization without filter or scavenger | No intervention | –Subject will use a standard nebulizer |
| Nebulization with a filter or scavenger | Experimental | Device: Filter, Device: Scavenger face tentSubject 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 | No intervention | –Subject will use high-flow nasal cannula at 40 L/min |
| High-flow nasal cannula with a scavenger face tent | Experimental | Device: Scavenger face tentSubject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent |
| High-flow nasal cannula with a surgical mask | Active comparator | Device: FilterSubject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 18-65, Male or Female
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilterFilter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases | Device | High-flow nasal cannula with a surgical mask, Nebulization with a filter or scavenger |
| Scavenger face tentA 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 | Device | High-flow nasal cannula with a scavenger face tent, Nebulization with a filter or scavenger |
Primary outcome
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
1 secondary outcome
subject's comfort
Time frame: 5 minutes after using the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Results publication: PubMed 32543913Dhand 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.
- Results publication: PubMed 32299867Li 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.
- Results publication: PubMed 32783675Fink 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.
- Results publication: PubMed 32967700Kaur 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.
- Individual participant dataSharing planned: No. individual participant data would not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Li, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filter and Scavenger face tent in people with Transmission, Patient-Professional, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aerosol particle concentrations at 1 foot away from subject's face (time frame: 5 mins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04681599, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.