Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353531
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease Intervention/treatment
Transmission, Patient Professional High-flow Nasal Cannula Device: High-flow nasal cannula Device: Surgical mask Procedure: bronchoscopy examination Procedure: intubation Procedure: tracheostomy Device: nebulization Diagnostic Test: Pulmonary function test

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: High-flow 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.
    Other Name: HFNC, high-flow high humidity nasal cannula
  • Device: Surgical mask
    A procedure mask will be used to cover patient's face after HFNC is initiated.
    Other Name: procedure mask
  • Procedure: bronchoscopy examination
    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
  • Procedure: intubation
    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.
  • Procedure: tracheostomy
    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.
  • Device: nebulization
    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
  • Diagnostic Test: Pulmonary function 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

• Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests

Exclusion Criteria:

• No need for any respiratory therapy

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353531


Locations
Layout table for location information
United States, Illinois
Rush university medical center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jie Li, PhD Rush University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04353531    
Other Study ID Numbers: COVID19-aerosol
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data may be shared for research purpose based on request