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

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ClinicalTrials.gov Identifier: NCT04654754
Recruitment Status : Completed
First Posted : December 4, 2020
Results First Posted : November 22, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Jie Li, Rush University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transmission, Patient-Professional Device: high-flow high humidity oxygen device with tracheostomy adapter Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (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
Primary Purpose: Other
Official Title: Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial
Actual Study Start Date : December 23, 2020
Actual Primary Completion Date : July 16, 2021
Actual Study Completion Date : July 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: high-flow high humidity oxygen device with tracheostomy adapter
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
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other Name: Airvo2, Fisher & Paykel Healthcare Ltd
Active Comparator: large-volume nebulizer (cool aerosol) with trach collar
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
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other Name: Airvo2, Fisher & Paykel Healthcare Ltd
Placebo Comparator: Venturi-adapter with trach collar
This device did not provide any humidification but only oxygen
 Device: high-flow high humidity oxygen device with tracheostomy adapter
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other Name: Airvo2, Fisher & Paykel Healthcare Ltd
Experimental: large-volume nebulizer (cool aerosol) with T-piece and a filter
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
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other Name: Airvo2, Fisher & Paykel Healthcare Ltd
Experimental: high-flow high humidity device with a scavenger or a surgical mask
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
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
Other Name: Airvo2, Fisher & Paykel Healthcare Ltd


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654754


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Jie Li
Investigators
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Principal Investigator: Jie Li, PhD Rush University
  Study Documents (Full-Text)

Documents provided by Jie Li, Rush University Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] December 13, 2020
Informed Consent Form  [PDF] December 13, 2020

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jie Li, Associate professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04654754    
Other Study ID Numbers: HFOT-trach-aerosol
First Posted: December 4, 2020    Key Record Dates
Results First Posted: November 22, 2022
Last Update Posted: December 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are available upon reasonable request. Proposals should be directed to the corresponding author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jie Li, Rush University Medical Center:
aerosol generating procedure
tracheostomy
oxygen therapy