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

Jie Li1 site in 1 country12 target enrollmentStarted: December 23, 2020Last updated: December 21, 2022

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 12
Locations: 1
Primary Endpoint: Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Other
Masking: Single (Outcomes Assessor)

Masking Description

the device utilized in the study will be labeled as 1,2,3,4 and 5, the investigator who performed the statistical analysis will be blinded for the device

Eligibility Criteria

Ages: 18 Years to 90 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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

Arms & Interventions

high-flow high humidity oxygen device with tracheostomy adapter

Experimental

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.

Intervention: high-flow high humidity oxygen device with tracheostomy adapter (Device)

large-volume nebulizer (cool aerosol) with trach collar

Active Comparator

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

Intervention: high-flow high humidity oxygen device with tracheostomy adapter (Device)

Venturi-adapter with trach collar

Placebo Comparator

This device did not provide any humidification but only oxygen

Intervention: high-flow high humidity oxygen device with tracheostomy adapter (Device)

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

Experimental

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

Intervention: high-flow high humidity oxygen device with tracheostomy adapter (Device)

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

Experimental

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

Intervention: high-flow high humidity oxygen device with tracheostomy adapter (Device)