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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Venturi-adapter with trach collar | Placebo Comparator | This device did not provide any humidification but only oxygen |
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| 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 |
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| high-flow high humidity device with a scavenger or a surgical mask | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | 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 minutes after using the device |
| Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | 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 minutes after using the device |
| Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | 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 minutes after using the device |
| Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | 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 minutes after using the device |
| Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | 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 minutes after using the device |
| Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort With Different Oxygen Devices | Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable. | 5 minutes after using the device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Li, PhD | Rush University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32967700 | Background | Kaur R, Weiss TT, Perez A, Fink JB, Chen R, Luo F, Liang Z, Mirza S, Li J. Practical strategies to reduce nosocomial transmission to healthcare professionals providing respiratory care to patients with COVID-19. Crit Care. 2020 Sep 23;24(1):571. doi: 10.1186/s13054-020-03231-8. | |
| 32543913 | Result | Dhand R, Li J. Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2. Am J Respir Crit Care Med. 2020 Sep 1;202(5):651-659. doi: 10.1164/rccm.202004-1263PP. No abstract available. |
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Data are available upon reasonable request. Proposals should be directed to the corresponding author
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This is a randomized crossover study, all the 12 patients received the five treatments in a random order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spontaneous Breathing Patients With Tracheostomy | Patients who received tracheostomy and had spontaneous breathing, without ventilator support |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LVN With T-piece and a Filter |
| |||||||||||||
| High-flow High-humidity With Adapter |
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| LVN With Trach Collar |
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| Venturi With Trach Collar |
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| High-flow High-humidity With Scavenger |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spontaneous Breathing Patients With Tracheostomy | Patients who had tracheostomy and spontaneous breathing, without ventilator support |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
|
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3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spontaneous Breathing Patients With Tracheostomy | Patients who had tracheostomy and could breathe spontaneously without ventilator support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jie Li | Rush University | 3125634643 | jie_li@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2020 | Aug 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2020 | Aug 17, 2022 | ICF_001.pdf |
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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.
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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
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
|
|
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 minutes after using the device |
| 32299867 | Result | Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May. |
| 30705129 | Result | Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr. |
| 32783675 | Result | Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C, Martin AR, Rothen-Rutishauser B, Kuehl PJ, Haussermann S, MacLoughlin R, Smaldone GC, Muellinger B, Corcoran TE, Dhand R. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine. J Aerosol Med Pulm Drug Deliv. 2020 Dec;33(6):300-304. doi: 10.1089/jamp.2020.1615. Epub 2020 Aug 12. |
| 32556788 | Result | Rovira A, Dawson D, Walker A, Tornari C, Dinham A, Foden N, Surda P, Archer S, Lonsdale D, Ball J, Ofo E, Karagama Y, Odutoye T, Little S, Simo R, Arora A. Tracheostomy care and decannulation during the COVID-19 pandemic. A multidisciplinary clinical practice guideline. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):313-321. doi: 10.1007/s00405-020-06126-0. Epub 2020 Jun 17. |
| 32422180 | Result | McGrath BA, Brenner MJ, Warrillow SJ, Pandian V, Arora A, Cameron TS, Anon JM, Hernandez Martinez G, Truog RD, Block SD, Lui GCY, McDonald C, Rassekh CH, Atkins J, Qiang L, Vergez S, Dulguerov P, Zenk J, Antonelli M, Pelosi P, Walsh BK, Ward E, Shang Y, Gasparini S, Donati A, Singer M, Openshaw PJM, Tolley N, Markel H, Feller-Kopman DJ. Tracheostomy in the COVID-19 era: global and multidisciplinary guidance. Lancet Respir Med. 2020 Jul;8(7):717-725. doi: 10.1016/S2213-2600(20)30230-7. Epub 2020 May 15. |
| 28990261 | Result | Birk R, Handel A, Wenzel A, Kramer B, Aderhold C, Hormann K, Stuck BA, Sommer JU. Heated air humidification versus cold air nebulization in newly tracheostomized patients. Head Neck. 2017 Dec;39(12):2481-2487. doi: 10.1002/hed.24917. Epub 2017 Oct 9. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
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|
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| Primary | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
|
|
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| Primary | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
|
|
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| Primary | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
|
|
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| Primary | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | 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 | Posted | Median | Inter-Quartile Range | particles/m3 | 5 minutes after using the device |
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| Secondary | Patient Comfort With Different Oxygen Devices | Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable. | Posted | Mean | Standard Deviation | score on a scale (comfort scores 1-5) | 5 minutes after using the device |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| Title | Measurements |
|---|---|
|
| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|
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| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|
|
| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|
| Title | Measurements |
|---|---|
|
| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|
| Title | Measurements |
|---|---|
|
| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|
|
| Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter |
|
| High-flow High Humidity Device With a Scavenger or a Surgical Mask |
|