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
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Sponsor:
Jie Li
Information provided by (Responsible Party):
Jie Li, Rush University Medical Center
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 25, 2020 | ||||||
First Posted Date ICMJE | December 4, 2020 | ||||||
Results First Submitted Date ICMJE | August 17, 2022 | ||||||
Results First Posted Date ICMJE | November 22, 2022 | ||||||
Last Update Posted Date | December 21, 2022 | ||||||
Actual Study Start Date ICMJE | December 23, 2020 | ||||||
Actual Primary Completion Date | July 16, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
patient comfort with different oxygen devices [ Time Frame: 5 minutes after using the device ] patients would scale their comfort at a 5-point Likert scale
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy | ||||||
Official Title ICMJE | Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial | ||||||
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 Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | 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
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Condition ICMJE | Transmission, Patient-Professional | ||||||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
12 | ||||||
Original Estimated Enrollment ICMJE |
10 | ||||||
Actual Study Completion Date ICMJE | July 16, 2021 | ||||||
Actual Primary Completion Date | July 16, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04654754 | ||||||
Other Study ID Numbers ICMJE | HFOT-trach-aerosol | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Jie Li, Rush University Medical Center | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Jie Li | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Rush University Medical Center | ||||||
Verification Date | November 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |