Transmission, Patient-ProfessionalNCT04654754

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

A study testing high-flow high humidity oxygen device with tracheostomy adapter in people with Transmission, Patient-Professional, run by Jie Li at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Transmission, Patient-Professional
What is being tested?: high-flow high humidity oxygen device with tracheostomy adapter
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 23 Dec 2020to 16 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults;
tracheostomy;
able to spontaneous breathing without ventilator support

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial

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.

Read the 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.

Conditions: Transmission, Patient-Professional
Being tested: high-flow high humidity oxygen device with tracheostomy adapter
Keywords: aerosol generating procedure, tracheostomy, oxygen therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high-flow high humidity oxygen device with tracheostomy adapterDevice
Also called Airvo2, Fisher & Paykel Healthcare Ltd
This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

Study groups in NCT04654754
Study group	Role	What they receive
high-flow high humidity oxygen device with tracheostomy adapter	Experimental	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. Receives: Device: high-flow high humidity oxygen device with tracheostomy adapter
large-volume nebulizer (cool aerosol) with trach collar	Active comparator	This device is the conventional device that is commonly utilized to provide humidification for spontaneous breathing patients with tracheostomy. Receives: Device: high-flow high humidity oxygen device with tracheostomy adapter
Venturi-adapter with trach collar	Placebo comparator	This device did not provide any humidification but only oxygen Receives: Device: high-flow high humidity oxygen device with tracheostomy adapter
large-volume nebulizer (cool aerosol) with T-piece and a filter	Experimental	this device is added with a filter, in order to reduce aerosol particle concentrations in the surrounding environment Receives: Device: high-flow high humidity oxygen device with tracheostomy adapter
high-flow high humidity device with a scavenger or a surgical mask	Experimental	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 Receives: Device: high-flow high humidity oxygen device with tracheostomy adapter

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 5 minutes after using the device
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
Measured: 5 minutes after using the device
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
Measured: 5 minutes after using the device
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
Measured: 5 minutes after using the device
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
Measured: 5 minutes after using the device
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
Measured: 5 minutes after using the device

Secondary outcomes (1)

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.
Measured: 5 minutes after using the device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 202016 Jul 2021

First posted4 Dec 2020
Study start23 Dec 2020
Primary completion16 Jul 2021
Study completion16 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Transmission, Patient-ProfessionalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04654754
Sponsor's protocol ID: HFOT-trach-aerosol
Status last verified: Nov 2022
First submitted: 25 Nov 2020
Last updated: 21 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data are available upon reasonable request. Proposals should be directed to the corresponding author

Publications

Kaur R, Weiss TT, Perez A, Fink JB, Chen R, Luo F, Liang Z, Mirza S, Li J. Practical strategies to reduce nosocomial transmission to healthcare professionals providing respiratory care to patients with COVID-19. Crit Care. 2020 Sep 23;24(1):571. doi: 10.1186/s13054-020-03231-8.
PubMed 32967700
Dhand R, Li J. Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2. Am J Respir Crit Care Med. 2020 Sep 1;202(5):651-659. doi: 10.1164/rccm.202004-1263PP. No abstract available.
PubMed 32543913
Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May.
PubMed 32299867
Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr.
PubMed 30705129
Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C, Martin AR, Rothen-Rutishauser B, Kuehl PJ, Haussermann S, MacLoughlin R, Smaldone GC, Muellinger B, Corcoran TE, Dhand R. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine. J Aerosol Med Pulm Drug Deliv. 2020 Dec;33(6):300-304. doi: 10.1089/jamp.2020.1615. Epub 2020 Aug 12.
PubMed 32783675
Rovira A, Dawson D, Walker A, Tornari C, Dinham A, Foden N, Surda P, Archer S, Lonsdale D, Ball J, Ofo E, Karagama Y, Odutoye T, Little S, Simo R, Arora A. Tracheostomy care and decannulation during the COVID-19 pandemic. A multidisciplinary clinical practice guideline. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):313-321. doi: 10.1007/s00405-020-06126-0. Epub 2020 Jun 17.
PubMed 32556788
McGrath BA, Brenner MJ, Warrillow SJ, Pandian V, Arora A, Cameron TS, Anon JM, Hernandez Martinez G, Truog RD, Block SD, Lui GCY, McDonald C, Rassekh CH, Atkins J, Qiang L, Vergez S, Dulguerov P, Zenk J, Antonelli M, Pelosi P, Walsh BK, Ward E, Shang Y, Gasparini S, Donati A, Singer M, Openshaw PJM, Tolley N, Markel H, Feller-Kopman DJ. Tracheostomy in the COVID-19 era: global and multidisciplinary guidance. Lancet Respir Med. 2020 Jul;8(7):717-725. doi: 10.1016/S2213-2600(20)30230-7. Epub 2020 May 15.
PubMed 32422180
Birk R, Handel A, Wenzel A, Kramer B, Aderhold C, Hormann K, Stuck BA, Sommer JU. Heated air humidification versus cold air nebulization in newly tracheostomized patients. Head Neck. 2017 Dec;39(12):2481-2487. doi: 10.1002/hed.24917. Epub 2017 Oct 9.
PubMed 28990261

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial
ClinicalTrials.gov ID: NCT04654754
Acronym / sponsor ID: HFOT-trach-aerosol
Conditions: Transmission, Patient-Professional
Keywords: aerosol generating procedure, tracheostomy, oxygen therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Jie LiUniversity, hospital or other
Study start: 23 Dec 2020 (actual)
Primary completion: 16 Jul 2021 (actual)
Study completion: 16 Jul 2021 (actual)
First posted: 4 Dec 2020 (actual)
Results: Posted 22 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 5
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.

Arm	Type	Receives
high-flow high humidity oxygen device with tracheostomy adapter	Experimental	Device: high-flow high humidity oxygen device with tracheostomy adapterThis device provides high-flow gas to tracheostomy patients with heat and humidification. A special adapter is used to connect the tracheostomy tube and circuit.
large-volume nebulizer (cool aerosol) with trach collar	Active comparator	Device: high-flow high humidity oxygen device with tracheostomy adapterThis device is the conventional device that is commonly utilized to provide humidification for spontaneous breathing patients with tracheostomy.
Venturi-adapter with trach collar	Placebo comparator	Device: high-flow high humidity oxygen device with tracheostomy adapterThis device did not provide any humidification but only oxygen
large-volume nebulizer (cool aerosol) with T-piece and a filter	Experimental	Device: high-flow high humidity oxygen device with tracheostomy adapterthis device is added with a filter, in order to reduce aerosol particle concentrations in the surrounding environment
high-flow high humidity device with a scavenger or a surgical mask	Experimental	Device: high-flow high humidity oxygen device with tracheostomy adapterthis device is added with a scavenger or a surgical mask over the adapter, in order to reduce aerosol particle concentrations in the surrounding environment

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

adults;
tracheostomy;
able to spontaneous breathing without ventilator support

Key exclusion criteria (6 listed)

confirmed diagnosis of COVID-19 within recent two weeks;
non-English speaking;
refuse to participate in the study;
palliative care;
receiving ECMO;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high-flow high humidity oxygen device with tracheostomy adapterAlso: Airvo2, Fisher & Paykel Healthcare LtdThis device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.	Device	Venturi-adapter with trach collar, high-flow high humidity device with a scavenger or a surgical mask, high-flow high humidity oxygen device with tracheostomy adapter, large-volume nebulizer (cool aerosol) with T-piece and a filter, large-volume nebulizer (cool aerosol) with trach collar

Primary outcome

Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient
Time frame: 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
Time frame: 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 0.3-0.5 Micrometer at 1 Foot Away From the Patient
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

1 secondary outcome

Patient Comfort With Different Oxygen Devices
Time frame: 5 minutes after using the device

Results and safety

Results posted to the registry on 22 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spontaneous Breathing Patients With Tracheostomy	12	12

Primary outcome: Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient

Time frame: 5 minutes after using the device. Median (Inter-Quartile Range). Unit: particles/m3

Measure	Spontaneous Breathing Patients With Tracheostomy n = 12
High-flow High Humidity Oxygen Device With Tracheostomy Adapter	13000 (10000 to 31000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar	11000 (6000 to 29000)
Venturi-adapter With Trach Collar	10000 (8000 to 23000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter	12000 (7000 to 26000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask	13000 (9000 to 25000)

Primary outcome: Aerosol Particle Concentrations With Size of <0.3 Micrometer at 1 Foot Away From the Patient

Time frame: 5 minutes after using the device. Median (Inter-Quartile Range). Unit: particles/m3

Measure	Spontaneous Breathing Patients With Tracheostomy n = 12
High-flow High Humidity Oxygen Device With Tracheostomy Adapter	10500000 (7700000 to 23000000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar	15200000 (7200000 to 26000000)
Venturi-adapter With Trach Collar	12100000 (6900000 to 26600000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter	11900000 (7300000 to 25500000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask	13000000 (7900000 to 25400000)

Primary outcome: Aerosol Particle Concentrations With Size of 0.3-0.5 Micrometer at 1 Foot Away From the Patient

Time frame: 5 minutes after using the device. Median (Inter-Quartile Range). Unit: particles/m3

Measure	Spontaneous Breathing Patients With Tracheostomy n = 12
High-flow High Humidity Oxygen Device With Tracheostomy Adapter	610000 (460000 to 1790000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar	730000 (380000 to 3150000)
Venturi-adapter With Trach Collar	610000 (360000 to 1210000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter	590000 (390000 to 1760000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask	680000 (410000 to 1960000)

Primary outcome: Aerosol Particle Concentrations With Size of 0.5-1 Micrometer at 1 Foot Away From the Patient

Time frame: 5 minutes after using the device. Median (Inter-Quartile Range). Unit: particles/m3

Measure	Spontaneous Breathing Patients With Tracheostomy n = 12
High-flow High Humidity Oxygen Device With Tracheostomy Adapter	53000 (35000 to 137000)
Large-volume Nebulizer (Cool Aerosol) With Trach Collar	55000 (36000 to 140000)
Venturi-adapter With Trach Collar	46000 (36000 to 132000)
Large-volume Nebulizer (Cool Aerosol) With T-piece and a Filter	52000 (36000 to 101000)
High-flow High Humidity Device With a Scavenger or a Surgical Mask	50000 (42000 to 139000)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spontaneous Breathing Patients With Tracheostomy	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32967700Kaur R, Weiss TT, Perez A, Fink JB, Chen R, Luo F, Liang Z, Mirza S, Li J. Practical strategies to reduce nosocomial transmission to healthcare professionals providing respiratory care to patients with COVID-19. Crit Care. 2020 Sep 23;24(1):571. doi: 10.1186/s13054-020-03231-8.
Results publication: PubMed 32543913Dhand R, Li J. Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2. Am J Respir Crit Care Med. 2020 Sep 1;202(5):651-659. doi: 10.1164/rccm.202004-1263PP. No abstract available.
Results publication: PubMed 32299867Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May.
Results publication: PubMed 30705129Hui DS, Chow BK, Lo T, Tsang OTY, Ko FW, Ng SS, Gin T, Chan MTV. Exhaled air dispersion during high-flow nasal cannula therapy versus CPAP via different masks. Eur Respir J. 2019 Apr 11;53(4):1802339. doi: 10.1183/13993003.02339-2018. Print 2019 Apr.
Results publication: PubMed 32783675Fink JB, Ehrmann S, Li J, Dailey P, McKiernan P, Darquenne C, Martin AR, Rothen-Rutishauser B, Kuehl PJ, Haussermann S, MacLoughlin R, Smaldone GC, Muellinger B, Corcoran TE, Dhand R. Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine. J Aerosol Med Pulm Drug Deliv. 2020 Dec;33(6):300-304. doi: 10.1089/jamp.2020.1615. Epub 2020 Aug 12.
Results publication: PubMed 32556788Rovira A, Dawson D, Walker A, Tornari C, Dinham A, Foden N, Surda P, Archer S, Lonsdale D, Ball J, Ofo E, Karagama Y, Odutoye T, Little S, Simo R, Arora A. Tracheostomy care and decannulation during the COVID-19 pandemic. A multidisciplinary clinical practice guideline. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):313-321. doi: 10.1007/s00405-020-06126-0. Epub 2020 Jun 17.
Results publication: PubMed 32422180McGrath BA, Brenner MJ, Warrillow SJ, Pandian V, Arora A, Cameron TS, Anon JM, Hernandez Martinez G, Truog RD, Block SD, Lui GCY, McDonald C, Rassekh CH, Atkins J, Qiang L, Vergez S, Dulguerov P, Zenk J, Antonelli M, Pelosi P, Walsh BK, Ward E, Shang Y, Gasparini S, Donati A, Singer M, Openshaw PJM, Tolley N, Markel H, Feller-Kopman DJ. Tracheostomy in the COVID-19 era: global and multidisciplinary guidance. Lancet Respir Med. 2020 Jul;8(7):717-725. doi: 10.1016/S2213-2600(20)30230-7. Epub 2020 May 15.
Results publication: PubMed 28990261Birk R, Handel A, Wenzel A, Kramer B, Aderhold C, Hormann K, Stuck BA, Sommer JU. Heated air humidification versus cold air nebulization in newly tracheostomized patients. Head Neck. 2017 Dec;39(12):2481-2487. doi: 10.1002/hed.24917. Epub 2017 Oct 9.
Individual participant dataSharing planned: No. Data are available upon reasonable request. Proposals should be directed to the corresponding author

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Li, PhD principal investigator

Rush University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing high-flow high humidity oxygen device with tracheostomy adapter in people with Transmission, Patient-Professional, run by Jie Li at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerosol Particle Concentrations With Size of 1-3 Micrometer at 1 Foot Away From the Patient (time frame: 5 minutes after using the device). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04654754, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.