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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%) 
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:
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