Transmission, Patient ProfessionalNCT04353531
Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
An observational study of Transmission, Patient Professional and High-flow Nasal Cannula, run by Rush University Medical Center at 1 site in United States.
Trial summary
Massive number of clinicians were infected during the outbreak of COVID-19, which raised the concerns of utilizing "aerosol generating procedures", particularly the use of high-flow nasal cannula, noninvasive ventilation, intubation, bronchoscopy examination and pulmonary function test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transmission, Patient Professional, High-flow Nasal Cannula
- What is being tested?
- High-flow nasal cannula, Surgical mask and bronchoscopy examination
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 30 Aug 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are diagnosed as COVID-19 infection and admitted to adult ICU will be enrolled in Rush University Medical Center, Chicago, IL, USA. Patients will be excluded if patients do not require any respiratory treatments.
Who may be able to join
- Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests
Who cannot join
- No need for any respiratory therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush university medical center
Chicago, Illinois, 60612
About this study
Official title: An Observational Study to Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
Massive number of clinicians were infected during the outbreak of COVID-19, which raised the concerns of utilizing "aerosol generating procedures", particularly the use of high-flow nasal cannula, noninvasive ventilation, intubation, bronchoscopy examination and pulmonary function test. There appears to be a trend to avoid those treatments. Instead, aggressive intubation might cause shortage of medical devices and add extra workload. Therefore, we aimed to do a clinical observational study to evaluate the aerosol generation in these procedures and explore the potential measures to reduce the aerosol generation or dispersion.
Read the detailed description
The intent is to monitor exhaled aerosol produced by COVID-19 patients pre and post aerosol generating procedures. Monitoring will occur at a distance of 1 and 3 feet from the subject's airway. This observational study will be conducted in standard patient hospital rooms (standard or negative pressure room).
- Being tested
- High-flow nasal cannula, Surgical mask, bronchoscopy examination, intubation, tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulaDevice
Also called HFNC, high-flow high humidity nasal cannula
High-flow nasal cannula is a modality of oxygen device that can provide gas flow meets or exceeds patient inspiratory flow demand (flow can be set at 10-60 L/min), it has been proven to improve oxygenation and reduce intubation rate in hypoxemic patients.
Surgical maskDevice
Also called procedure mask
A procedure mask will be used to cover patient's face after HFNC is initiated.
bronchoscopy examinationProcedure or surgery
is a procedure that allows a doctor to examine the inside of the lungs, including the bronchi, which are the main pathways into the lungs. During a bronchoscopy, a doctor inserts a thin tube containing a light and camera into the lungs through the nose or mouth or via artificial airway such as intubation or tracheotomy tube
intubationProcedure or surgery
Intubation is the process of inserting a tube, called an endotracheal tube (ET), through the mouth and then into the airway. This is done so that a patient can be placed on a ventilator to assist with breathing during anesthesia, sedation, or severe illness.
tracheostomyProcedure or surgery
A tracheostomy is a medical procedure - either temporary or permanent - that involves creating an opening in the neck in order to place a tube into a person's windpipe. The tube is inserted through a cut in the neck below the vocal cords. This allows air to enter the lungs.
nebulizationDevice
A nebulizer is a piece of medical equipment that a person with asthma or another respiratory condition can use to administer medication directly and quickly to the lungs
Pulmonary function testDiagnostic test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange.
What is being measured
The primary outcome is the main question the study is designed to answer.
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient's airway in the patient's room
Measured: 5 minutes before procedure/treatment
The virus load in the air sample pre procedure/treatment at 1 foot away from patient
The virus load in the air sample pre procedure/treatment at 1 foot away from patient's airway in the patient's room
Measured: 1 hour before procedure/treatment
The virus load in the air sample during/after procedure/treatment at 1 foot away from patient
The virus load in the air sample during/after procedure/treatment at 1 foot away from patient's airway in the patient's room
Measured: 1 hour during/after procedure/treatment
The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient
The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient's airway in the patient's room
Measured: 5 minutes before procedure/treatment
The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient
The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient's airway in the patient's room
Measured: during procedure/treatment
The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patient
The aerosol mass/count concentration during procedure/ treatment at 3 feet away from HFNC in the patient's room
Measured: during procedure/treatment
The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient
The aerosol mass/count concentration post procedure/ treatment at 1 foot away from HFNC in the patient's room
Measured: 5 minutes post procedure/treatment
The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient
The aerosol mass/count concentration 5 mins procedure/ treatment at 3 feet away from HFNC in the patient's room
Measured: 5 minutes post procedure/treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start20 May 2020
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transmission, Patient ProfessionalStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 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 Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353531
- Sponsor's protocol ID
- COVID19-aerosol
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: De-identified data may be shared for research purpose based on request
Publications
Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.
PubMed 32129805Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr.
PubMed 30705129Leung CCH, Joynt GM, Gomersall CD, Wong WT, Lee A, Ling L, Chan PKS, Lui PCW, Tsoi PCY, Ling CM, Hui M. Comparison of high-flow nasal cannula versus oxygen face mask for environmental bacterial contamination in critically ill pneumonia patients: a randomized controlled crossover trial. J Hosp Infect. 2019 Jan;101(1):84-87. doi: 10.1016/j.jhin.2018.10.007. Epub 2018 Oct 15.
PubMed 30336170Hui DS, Chow BK, Chu L, Ng SS, Lee N, Gin T, Chan MT. Exhaled air dispersion during coughing with and without wearing a surgical or N95 mask. PLoS One. 2012;7(12):e50845. doi: 10.1371/journal.pone.0050845. Epub 2012 Dec 5.
PubMed 23239991Johnson DF, Druce JD, Birch C, Grayson ML. A quantitative assessment of the efficacy of surgical and N95 masks to filter influenza virus in patients with acute influenza infection. Clin Infect Dis. 2009 Jul 15;49(2):275-7. doi: 10.1086/600041.
PubMed 19522650Li J, Jing G, Fink JB, Porszasz J, Moran EM, Kiourkas RD, McLaughlin R, Vines DL, Dhand R. Airborne Particulate Concentrations During and After Pulmonary Function Testing. Chest. 2021 Apr;159(4):1570-1574. doi: 10.1016/j.chest.2020.10.064. Epub 2020 Nov 1. No abstract available.
PubMed 33144080
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
- ClinicalTrials.gov ID
- NCT04353531
- Acronym / sponsor ID
- COVID19-aerosol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 20 Apr 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.
Massive number of clinicians were infected during the outbreak of COVID-19, which raised the concerns of utilizing "aerosol generating procedures", particularly the use of high-flow nasal cannula, noninvasive ventilation, intubation, bronchoscopy examination and pulmonary function test. There appears to be a trend to avoid those treatments. Instead, aggressive intubation might cause shortage of medical devices and add extra workload. Therefore, we aimed to do a clinical observational study to evaluate the aerosol generation in these procedures and explore the potential measures to reduce the aerosol generation or dispersion.
Detailed description
The intent is to monitor exhaled aerosol produced by COVID-19 patients pre and post aerosol generating procedures. Monitoring will occur at a distance of 1 and 3 feet from the subject's airway. This observational study will be conducted in standard patient hospital rooms (standard or negative pressure room).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are diagnosed as COVID-19 infection and admitted to adult ICU will be enrolled in Rush University Medical Center, Chicago, IL, USA. Patients will be excluded if patients do not require any respiratory treatments.
Key inclusion criteria (1 listed)
- Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests
Key exclusion criteria (1 listed)
- No need for any respiratory therapy
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 |
|---|---|---|
| High-flow nasal cannulaAlso: HFNC, high-flow high humidity nasal cannulaHigh-flow nasal cannula is a modality of oxygen device that can provide gas flow meets or exceeds patient inspiratory flow demand (flow can be set at 10-60 L/min), it has been proven to improve oxygenation and reduce intubation rate in hypoxemic patients. | Device | – |
| Surgical maskAlso: procedure maskA procedure mask will be used to cover patient's face after HFNC is initiated. | Device | – |
| bronchoscopy examinationis a procedure that allows a doctor to examine the inside of the lungs, including the bronchi, which are the main pathways into the lungs. During a bronchoscopy, a doctor inserts a thin tube containing a light and camera into the lungs through the nose or mouth or via artificial airway such as intubation or tracheotomy tube | Procedure or surgery | – |
| intubationIntubation is the process of inserting a tube, called an endotracheal tube (ET), through the mouth and then into the airway. This is done so that a patient can be placed on a ventilator to assist with breathing during anesthesia, sedation, or severe illness. | Procedure or surgery | – |
| tracheostomyA tracheostomy is a medical procedure - either temporary or permanent - that involves creating an opening in the neck in order to place a tube into a person's windpipe. The tube is inserted through a cut in the neck below the vocal cords. This allows air to enter the lungs. | Procedure or surgery | – |
| nebulizationA nebulizer is a piece of medical equipment that a person with asthma or another respiratory condition can use to administer medication directly and quickly to the lungs | Device | – |
| Pulmonary function testPulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. | Diagnostic test | – |
Primary outcome
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient
Time frame: 5 minutes before procedure/treatment
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient's airway in the patient's room
The virus load in the air sample pre procedure/treatment at 1 foot away from patient
Time frame: 1 hour before procedure/treatment
The virus load in the air sample pre procedure/treatment at 1 foot away from patient's airway in the patient's room
The virus load in the air sample during/after procedure/treatment at 1 foot away from patient
Time frame: 1 hour during/after procedure/treatment
The virus load in the air sample during/after procedure/treatment at 1 foot away from patient's airway in the patient's room
The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient
Time frame: 5 minutes before procedure/treatment
The aerosol mass/count concentration pre procedure/treatment at 3 feet away from patient's airway in the patient's room
The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient
Time frame: during procedure/treatment
The aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient's airway in the patient's room
The aerosol mass/count concentration during procedure/ treatment at 3 feet away from patient
Time frame: during procedure/treatment
The aerosol mass/count concentration during procedure/ treatment at 3 feet away from HFNC in the patient's room
The aerosol mass/count concentration post procedure/ treatment at 1 foot away from patient
Time frame: 5 minutes post procedure/treatment
The aerosol mass/count concentration post procedure/ treatment at 1 foot away from HFNC in the patient's room
The aerosol mass/count concentration 5 mins post procedure/ treatment at 3 feet away from patient
Time frame: 5 minutes post procedure/treatment
The aerosol mass/count concentration 5 mins procedure/ treatment at 3 feet away from HFNC in the patient's room
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 23 Apr 2021.
- Background: PubMed 32129805Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.
- Background: PubMed 30705129Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr.
- Background: PubMed 30336170Leung CCH, Joynt GM, Gomersall CD, Wong WT, Lee A, Ling L, Chan PKS, Lui PCW, Tsoi PCY, Ling CM, Hui M. Comparison of high-flow nasal cannula versus oxygen face mask for environmental bacterial contamination in critically ill pneumonia patients: a randomized controlled crossover trial. J Hosp Infect. 2019 Jan;101(1):84-87. doi: 10.1016/j.jhin.2018.10.007. Epub 2018 Oct 15.
- Background: PubMed 23239991Hui DS, Chow BK, Chu L, Ng SS, Lee N, Gin T, Chan MT. Exhaled air dispersion during coughing with and without wearing a surgical or N95 mask. PLoS One. 2012;7(12):e50845. doi: 10.1371/journal.pone.0050845. Epub 2012 Dec 5.
- Background: PubMed 19522650Johnson DF, Druce JD, Birch C, Grayson ML. A quantitative assessment of the efficacy of surgical and N95 masks to filter influenza virus in patients with acute influenza infection. Clin Infect Dis. 2009 Jul 15;49(2):275-7. doi: 10.1086/600041.
- Derived from this study: PubMed 33144080Li J, Jing G, Fink JB, Porszasz J, Moran EM, Kiourkas RD, McLaughlin R, Vines DL, Dhand R. Airborne Particulate Concentrations During and After Pulmonary Function Testing. Chest. 2021 Apr;159(4):1570-1574. doi: 10.1016/j.chest.2020.10.064. Epub 2020 Nov 1. No abstract available.
- Individual participant dataSharing planned: Undecided. De-identified data may be shared for research purpose based on request
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 Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transmission, Patient Professional and High-flow Nasal Cannula, 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 1 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 23 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?
The aerosol mass/count concentration pre procedure/treatment at 1 foot away from patient (time frame: 5 minutes before procedure/treatment). The study lists 8 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 NCT04353531, which also lists 6 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 23 Apr 2021.