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Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654754
Recruitment Status : Completed
First Posted : December 4, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Jie Li, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE November 25, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date July 23, 2021
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
 (submitted: December 2, 2020)
  • aerosol particle concentrations at 1 foot away from patient [ Time Frame: 5 minutes after using the device ]
    aerosol particle concentrations at 1 foot away from patient
  • aerosol particle concentrations at 3 feet away from patient [ Time Frame: 5 minutes after using the device ]
    aerosol particle concentrations at 3 feet away from patient
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
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 and 3 feet 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
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
Study Arms  ICMJE
  • Experimental: high-flow high humidity oxygen device with tracheostomy adapter
    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.
    Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
  • Active Comparator: large-volume nebulizer (cool aerosol) with trach collar
    This device is the conventional device that is commonly utilized to provide humidification for spontaneous breathing patients with tracheostomy.
    Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
  • Placebo Comparator: Venturi-adapter with trach collar
    This device did not provide any humidification but only oxygen
    Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
  • Experimental: large-volume nebulizer (cool aerosol) with T-piece and a filter
    this device is added with a filter, in order to reduce aerosol particle concentrations in the surrounding environment
    Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
  • Experimental: high-flow high humidity device with a scavenger or a surgical mask
    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
    Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2020)
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:

  • adults;
  • tracheostomy;
  • able to spontaneous breathing without ventilator support

Exclusion Criteria:

  • confirmed diagnosis of COVID-19 within recent two weeks;
  • non-English speaking;
  • refuse to participate in the study;
  • palliative care;
  • receiving ECMO;
  • unable to connect with tracheostomy adapter, such as laryngectomy tube
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data are available upon reasonable request. Proposals should be directed to the corresponding author
Responsible Party Jie Li, Rush University Medical Center
Study Sponsor  ICMJE Jie Li
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jie Li, PhD Rush University
PRS Account Rush University Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP