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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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Spontaneous Breathing Patients With Tracheostomy | |
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Patients who had tracheostomy and spontaneous breathing, without ventilator support | |
Overall Number of Baseline Participants | 12 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 12 participants | |
50.5 (16.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | |
Female |
6 50.0%
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Male |
6 50.0%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | |
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Jie Li |
Organization: | Rush University |
Phone: | 3125634643 |
EMail: | jie_li@rush.edu |
Publications of Results:
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 |