N/A
Completed N=12
Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy
Transmission, Patient-Professional
Source: ClinicalTrials.gov NCT04654754 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient — 13000; 11000; 10000; 12000 particles/m3
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient |
13000; 11000; 10000; 12000; 13000 | — |
| PRIMARY Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient |
10500000; 15200000; 12100000; 11900000; 13000000 | — |
| PRIMARY Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient |
610000; 730000; 610000; 590000; 680000 | — |
| PRIMARY Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient |
53000; 55000; 46000; 52000; 50000 | — |
| PRIMARY Aerosol Particle Concentrations With Size of 3-5 Micrometer at 1 Foot Away From the Patient |
6700; 6000; 5700; 6000; 6700 | — |
| PRIMARY Aerosol Particle Concentrations With Size of 5-10 Micrometer at 1 Foot Away From the Patient |
3500; 3200; 3900; 3500; 3200 | — |
| SECONDARY Patient Comfort With Different Oxygen Devices |
3.5; 3.8; 3.5; 3.3; 3.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04654754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.