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

Jie Li1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2020年12月23日最近更新: 2022年12月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 12
试验地点: 1
主要终点: Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•tracheostomy;
•able to spontaneous breathing without ventilator support

排除标准

•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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: high-flow high humidity oxygen device with tracheostomy adapter (Device)