Transmission, Patient-Professional
Conditions
Keywords
aerosol generating procedure, tracheostomy, oxygen therapy
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.
Interventions
DEVICEhigh-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.
Sponsors
Jie Li
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
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
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 away from the patients will be measured.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
| Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
| Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
| Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
| Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
| Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | 5 minutes after using the device | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort With Different Oxygen Devices | 5 minutes after using the device | Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable. |
Countries
United States
Participant flow
Recruitment details
This is a randomized crossover study, all the 12 patients received the five treatments in a random order.
Participants by arm
| Arm | Count |
|---|---|
| Spontaneous Breathing Patients With Tracheostomy Patients who had tracheostomy and spontaneous breathing, without ventilator support | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Spontaneous Breathing Patients With Tracheostomy | — |
|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 16.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 610000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 730000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 610000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 590000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 680000 particles/m3 |
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 10500000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 15200000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 12100000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 11900000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 13000000 particles/m3 |
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 55000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 53000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 46000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 52000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 50000 particles/m3 |
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 13000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 11000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 10000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 12000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 13000 particles/m3 |
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 6000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 5700 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 6000 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 6700 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 6700 particles/m3 |
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
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 3500 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 3200 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | Venturi-adapter With Trach Collar | 3900 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 3500 particles/m3 |
| Spontaneous Breathing Patients With Tracheostomy | Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 3200 particles/m3 |
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.
Time frame: 5 minutes after using the device
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spontaneous Breathing Patients With Tracheostomy | Patient Comfort With Different Oxygen Devices | High-flow High Humidity Oxygen Device With Tracheostomy Adapter | 3.5 score on a scale (comfort scores 1-5) | Standard Deviation 1.5 |
| Spontaneous Breathing Patients With Tracheostomy | Patient Comfort With Different Oxygen Devices | Large-volume Nebulizer (Cool Aerosol) With Trach Collar | 3.8 score on a scale (comfort scores 1-5) | Standard Deviation 1.3 |
| Spontaneous Breathing Patients With Tracheostomy | Patient Comfort With Different Oxygen Devices | Venturi-adapter With Trach Collar | 3.5 score on a scale (comfort scores 1-5) | Standard Deviation 1.2 |
| Spontaneous Breathing Patients With Tracheostomy | Patient Comfort With Different Oxygen Devices | Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter | 3.3 score on a scale (comfort scores 1-5) | Standard Deviation 1.3 |
| Spontaneous Breathing Patients With Tracheostomy | Patient Comfort With Different Oxygen Devices | High-flow High Humidity Device With a Scavenger or a Surgical Mask | 3.5 score on a scale (comfort scores 1-5) | Standard Deviation 1.2 |