Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy

Study Overview
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Brief Summary
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For spontaneous breathing patients with tracheostomy, whose lower airway is directly opened to the room air, the aerosol particles generated by the patients would be directly dispersed into the room air, which might be an direct resource of virus transmission. However, the transmission risk has not been evaluated and the appropriate humidification therapy is unknown. Thus this study is aimed to investigate the aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.

Detailed Description
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The transmission route of the SARS-CoV-2 virus remains controversial, and concerns persist of potentially increased virus transmission when utilizing high-flow devices and aerosol devices among COVID-19 patients. For spontaneous breathing patients with tracheostomy, whose lower airway is directly opened to the room air, the aerosol particles generated by the patients would be directly dispersed into the room air, which might be an direct resource of virus transmission. However, the transmission risk of tracheostomy during spontaneous breathing has not been evaluated and the appropriate humidification therapy is unknown. Thus this study is aimed to investigate the aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.

Official Title
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Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial

Conditions
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Transmission, Patient-Professional

Intervention / Treatment
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* Device: high-flow high humidity oxygen device with tracheostomy adapter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults; tracheostomy; able to spontaneous breathing without ventilator support Exclusion Criteria: confirmed diagnosis of COVID-19 within recent two weeks; non-English speaking; refuse to participate in the study; palliative care; receiving ECMO; unable to connect with tracheostomy adapter, such as laryngectomy tube

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: five oxygen and humidification different devices will be used for the enrolled patients, with 5 minutes each. Aerosol particle concentrations at 1 foot away from the patients will be measured.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-flow high humidity oxygen device with tracheostomy adapter<br>This device provides high-flow gas to tracheostomy patients with heat and humidification. A special adapter is used to connect the tracheostomy tube and circuit. | Device: high-flow high humidity oxygen device with tracheostomy adapter<br>* This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.<br>* Other names: Airvo2, Fisher & Paykel Healthcare Ltd;|
| Active Comparator: large-volume nebulizer (cool aerosol) with trach collar<br>This device is the conventional device that is commonly utilized to provide humidification for spontaneous breathing patients with tracheostomy. | Device: high-flow high humidity oxygen device with tracheostomy adapter<br>* This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.<br>* Other names: Airvo2, Fisher & Paykel Healthcare Ltd;|
| Placebo Comparator: Venturi-adapter with trach collar<br>This device did not provide any humidification but only oxygen | Device: high-flow high humidity oxygen device with tracheostomy adapter<br>* This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.<br>* Other names: Airvo2, Fisher & Paykel Healthcare Ltd;|
| Experimental: large-volume nebulizer (cool aerosol) with T-piece and a filter<br>this device is added with a filter, in order to reduce aerosol particle concentrations in the surrounding environment | Device: high-flow high humidity oxygen device with tracheostomy adapter<br>* This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.<br>* Other names: Airvo2, Fisher & Paykel Healthcare Ltd;|
| Experimental: high-flow high humidity device with a scavenger or a surgical mask<br>this device is added with a scavenger or a surgical mask over the adapter, in order to reduce aerosol particle concentrations in the surrounding environment | Device: high-flow high humidity oxygen device with tracheostomy adapter<br>* This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.<br>* Other names: Airvo2, Fisher & Paykel Healthcare Ltd;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 
| Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 
| Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 
| Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 
| Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 
| Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | aerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient | 5 minutes after using the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort With Different Oxygen Devices | Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable. | 5 minutes after using the device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen therapy, aerosol generating procedure, tracheostomy