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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Transmission, Patient-Professional
Intervention Device: high-flow high humidity oxygen device with tracheostomy adapter
Enrollment 12
Recruitment Details This is a randomized crossover study, all the 12 patients received the five treatments in a random order.
Pre-assignment Details  
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Period Title: LVN With T-piece and a Filter
Started 12
Completed 12
Not Completed 0
Period Title: High-flow High-humidity With Adapter
Started 12
Completed 12
Not Completed 0
Period Title: LVN With Trach Collar
Started 12
Completed 12
Not Completed 0
Period Title: Venturi With Trach Collar
Started 12
Completed 12
Not Completed 0
Period Title: High-flow High-humidity With Scavenger
Started 12
Completed 12
Not Completed 0
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description Patients who had tracheostomy and spontaneous breathing, without ventilator support
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
50.5  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who had tracheostomy and could breathe spontaneously without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
13000
(10000 to 31000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
11000
(6000 to 29000)
Venturi-adapter With Trach Collar
10000
(8000 to 23000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
12000
(7000 to 26000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
13000
(9000 to 25000)
2.Primary Outcome
Title Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
10500000
(7700000 to 23000000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
15200000
(7200000 to 26000000)
Venturi-adapter With Trach Collar
12100000
(6900000 to 26600000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
11900000
(7300000 to 25500000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
13000000
(7900000 to 25400000)
3.Primary Outcome
Title Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
610000
(460000 to 1790000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
730000
(380000 to 3150000)
Venturi-adapter With Trach Collar
610000
(360000 to 1210000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
590000
(390000 to 1760000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
680000
(410000 to 1960000)
4.Primary Outcome
Title Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
53000
(35000 to 137000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
55000
(36000 to 140000)
Venturi-adapter With Trach Collar
46000
(36000 to 132000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
52000
(36000 to 101000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
50000
(42000 to 139000)
5.Primary Outcome
Title Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
6700
(5300 to 15200)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
6000
(2500 to 15500)
Venturi-adapter With Trach Collar
5700
(4600 to 12000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
6000
(3500 to 14100)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
6700
(4900 to 12700)
6.Primary Outcome
Title Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient
Hide Description 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
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: particles/m3
High-flow High Humidity Oxygen Device With Tracheostomy Adapter
3500
(2100 to 7100)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar
3200
(1400 to 7400)
Venturi-adapter With Trach Collar
3900
(1800 to 4600)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter
3500
(2500 to 6400)
High-flow High Humidity Device With a Scavenger or a Surgical Mask
3200
(2500 to 5300)
7.Secondary Outcome
Title Patient Comfort With Different Oxygen Devices
Hide Description Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable.
Time Frame 5 minutes after using the device
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description:
Patients who had tracheostomy and could breathe spontaneously without ventilator support
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: score on a scale (comfort scores 1-5)
High-flow High Humidity Oxygen Device With Tracheostomy Adapter 3.5  (1.5)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar 3.8  (1.3)
Venturi-adapter With Trach Collar 3.5  (1.2)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter 3.3  (1.3)
High-flow High Humidity Device With a Scavenger or a Surgical Mask 3.5  (1.2)
Time Frame 3 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spontaneous Breathing Patients With Tracheostomy
Hide Arm/Group Description Patients who had tracheostomy and could breathe spontaneously without ventilator support
All-Cause Mortality
Spontaneous Breathing Patients With Tracheostomy
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Spontaneous Breathing Patients With Tracheostomy
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spontaneous Breathing Patients With Tracheostomy
Affected / at Risk (%)
Total   0/12 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jie Li
Organization: Rush University
Phone: 3125634643
EMail: jie_li@rush.edu
Publications of Results:
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.
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.
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.
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.
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.
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.
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.
Other Publications:
Layout table for additonal information
Responsible Party: Jie Li, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04654754    
Other Study ID Numbers: HFOT-trach-aerosol
First Submitted: November 25, 2020
First Posted: December 4, 2020
Results First Submitted: August 17, 2022
Results First Posted: November 22, 2022
Last Update Posted: December 21, 2022