Trial Outcomes & Findings for Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy (NCT NCT04654754)
NCT ID: NCT04654754
Last Updated: 2022-12-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
5 minutes after using the device
Results posted on
2022-12-21
Participant Flow
This is a randomized crossover study, all the 12 patients received the five treatments in a random order.
Participant milestones
| Measure |
Spontaneous Breathing Patients With Tracheostomy
Patients who received tracheostomy and had spontaneous breathing, without ventilator support
|
|---|---|
|
LVN With T-piece and a Filter
STARTED
|
12
|
|
LVN With T-piece and a Filter
COMPLETED
|
12
|
|
LVN With T-piece and a Filter
NOT COMPLETED
|
0
|
|
High-flow High-humidity With Adapter
STARTED
|
12
|
|
High-flow High-humidity With Adapter
COMPLETED
|
12
|
|
High-flow High-humidity With Adapter
NOT COMPLETED
|
0
|
|
LVN With Trach Collar
STARTED
|
12
|
|
LVN With Trach Collar
COMPLETED
|
12
|
|
LVN With Trach Collar
NOT COMPLETED
|
0
|
|
Venturi With Trach Collar
STARTED
|
12
|
|
Venturi With Trach Collar
COMPLETED
|
12
|
|
Venturi With Trach Collar
NOT COMPLETED
|
0
|
|
High-flow High-humidity With Scavenger
STARTED
|
12
|
|
High-flow High-humidity With Scavenger
COMPLETED
|
12
|
|
High-flow High-humidity With Scavenger
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and spontaneous breathing, without ventilator support
|
|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 16.6 • n=12 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 6000.0 to 29000.0
|
|
Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient
Venturi-adapter With Trach Collar
|
10000 particles/m3
Interval 8000.0 to 23000.0
|
|
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
Interval 10000.0 to 31000.0
|
|
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
Interval 7000.0 to 26000.0
|
|
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
Interval 9000.0 to 25000.0
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 7700000.0 to 23000000.0
|
|
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
Interval 7200000.0 to 26000000.0
|
|
Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient
Venturi-adapter With Trach Collar
|
12100000 particles/m3
Interval 6900000.0 to 26600000.0
|
|
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
Interval 7300000.0 to 25500000.0
|
|
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
Interval 7900000.0 to 25400000.0
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 460000.0 to 1790000.0
|
|
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
Interval 380000.0 to 3150000.0
|
|
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
Interval 360000.0 to 1210000.0
|
|
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
Interval 390000.0 to 1760000.0
|
|
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
Interval 410000.0 to 1960000.0
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 35000.0 to 137000.0
|
|
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
Interval 36000.0 to 140000.0
|
|
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
Interval 36000.0 to 132000.0
|
|
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
Interval 36000.0 to 101000.0
|
|
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
Interval 42000.0 to 139000.0
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 5300.0 to 15200.0
|
|
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
Interval 2500.0 to 15500.0
|
|
Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient
Venturi-adapter With Trach Collar
|
5700 particles/m3
Interval 4600.0 to 12000.0
|
|
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
Interval 3500.0 to 14100.0
|
|
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
Interval 4900.0 to 12700.0
|
PRIMARY outcome
Timeframe: 5 minutes after using the deviceaerosol particle concentrations (the concentrations of particles inside the room air, the unit is particles per cubic meters) at 1 foot away from the patient
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
Interval 2500.0 to 5300.0
|
|
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
Interval 2100.0 to 7100.0
|
|
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
Interval 1400.0 to 7400.0
|
|
Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient
Venturi-adapter With Trach Collar
|
3900 particles/m3
Interval 1800.0 to 4600.0
|
|
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
Interval 2500.0 to 6400.0
|
SECONDARY outcome
Timeframe: 5 minutes after using the devicePatients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable.
Outcome measures
| Measure |
Spontaneous Breathing Patients With Tracheostomy
n=12 Participants
Patients who had tracheostomy and could breathe spontaneously without ventilator support
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Spontaneous Breathing Patients With Tracheostomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place