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

Jie Li

Status: Completed

Conditions: Transmission, Patient-Professional

Treatments: Device: high-flow high humidity oxygen device with tracheostomy adapter

Study type: Interventional

Funder types: Other

Identifiers

NCT04654754

HFOT-trach-aerosol

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 5 patient groups, including a placebo group

high-flow high humidity oxygen device with tracheostomy adapter

Experimental group

Description:

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.

Treatment:

Device: high-flow high humidity oxygen device with tracheostomy adapter

large-volume nebulizer (cool aerosol) with trach collar

Active Comparator group

Description:

This device is the conventional device that is commonly utilized to provide humidification for spontaneous breathing patients with tracheostomy.

Treatment:

Device: high-flow high humidity oxygen device with tracheostomy adapter

Venturi-adapter with trach collar

Placebo Comparator group

Description:

This device did not provide any humidification but only oxygen

Treatment:

Device: high-flow high humidity oxygen device with tracheostomy adapter

large-volume nebulizer (cool aerosol) with T-piece and a filter

Experimental group

Description:

this device is added with a filter, in order to reduce aerosol particle concentrations in the surrounding environment

Treatment:

Device: high-flow high humidity oxygen device with tracheostomy adapter

high-flow high humidity device with a scavenger or a surgical mask

Experimental group

Description:

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

Treatment:

Device: high-flow high humidity oxygen device with tracheostomy adapter