Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

Completed

• Conditions: Transmission, Patient Professional; High-flow Nasal Cannula

• Registration Number: NCT04353531
• Lead Sponsor: Rush University Medical Center

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.

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 Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-20
• Study Start: 2020-05-20
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The virus load in the air sample pre procedure/treatment at 1 foot away from patient	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 aerosol mass/count concentration and virus load in the air sample during procedure/treatment at 1 foot away from patient	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 post procedure/ treatment at 1 foot away from patient	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 pre procedure/treatment at 3 feet away from patient	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 pre procedure/treatment at 1 foot away from patient	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 during/after procedure/treatment at 1 foot away from patient	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 during procedure/ treatment at 3 feet away from patient	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 5 mins post procedure/ treatment at 3 feet away from patient	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

Trial Locations

Locations (1)

Rush university medical center; 🇺🇸 Chicago, Illinois, United States