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Completed

NCT Number: NCT04654754

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

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.

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Key information

Conditions

Transmission, Patient-Professional

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-flow high humidity oxygen device with tracheostomy adapter

Device

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

Other names: Airvo2, Fisher & Paykel Healthcare Ltd

Primary outcomes

  1. Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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

  2. Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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

  3. Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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

  4. Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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. Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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

  6. Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient

    Time frame: 5 minutes after using the device

    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

Secondary outcomes

  1. Patient Comfort With Different Oxygen Devices

    Time frame: 5 minutes after using the device

    Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable.

Sponsors and collaborators

Lead sponsor

Jie Li

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2020
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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