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

NCT ID: NCT04654754

Last Updated: 2022-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2021-07-16

Brief Summary

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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

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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

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Transmission, Patient-Professional

Keywords

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aerosol generating procedure tracheostomy oxygen therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

high-flow high humidity oxygen device with tracheostomy adapter

Intervention Type DEVICE

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

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.

Group Type ACTIVE_COMPARATOR

high-flow high humidity oxygen device with tracheostomy adapter

Intervention Type DEVICE

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

Venturi-adapter with trach collar

This device did not provide any humidification but only oxygen

Group Type PLACEBO_COMPARATOR

high-flow high humidity oxygen device with tracheostomy adapter

Intervention Type DEVICE

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

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

Group Type EXPERIMENTAL

high-flow high humidity oxygen device with tracheostomy adapter

Intervention Type DEVICE

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

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

Group Type EXPERIMENTAL

high-flow high humidity oxygen device with tracheostomy adapter

Intervention Type DEVICE

This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Airvo2, Fisher & Paykel Healthcare Ltd

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jie Li

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jie Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32967700 (View on PubMed)

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.

Reference Type RESULT
PMID: 32543913 (View on PubMed)

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.

Reference Type RESULT
PMID: 32299867 (View on PubMed)

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.

Reference Type RESULT
PMID: 30705129 (View on PubMed)

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.

Reference Type RESULT
PMID: 32783675 (View on PubMed)

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.

Reference Type RESULT
PMID: 32556788 (View on PubMed)

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.

Reference Type RESULT
PMID: 32422180 (View on PubMed)

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.

Reference Type RESULT
PMID: 28990261 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HFOT-trach-aerosol

Identifier Type: -

Identifier Source: org_study_id