NCT04654754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 22, 2022

Completed
Last Updated

December 21, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 25, 2020

Results QC Date

August 17, 2022

Last Update Submit

November 21, 2022

Conditions

Transmission, Patient-Professional

Keywords

aerosol generating proceduretracheostomyoxygen therapy

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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

    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

    5 minutes after using the device

Secondary Outcomes (1)

  • Patient Comfort With Different Oxygen Devices

    5 minutes after using the device

Study Arms (5)

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.

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.

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

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

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

Device: high-flow high humidity oxygen device with tracheostomy adapter

Interventions

high-flow high humidity oxygen device with tracheostomy adapterDEVICE

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

Also known as: Airvo2, Fisher & Paykel Healthcare Ltd
Venturi-adapter with trach collarhigh-flow high humidity device with a scavenger or a surgical maskhigh-flow high humidity oxygen device with tracheostomy adapterlarge-volume nebulizer (cool aerosol) with T-piece and a filterlarge-volume nebulizer (cool aerosol) with trach collar

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults;
  • tracheostomy;
  • able to spontaneous breathing without ventilator support

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (8)

  • 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.

    PMID: 32967700BACKGROUND

  • 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.

    PMID: 32543913RESULT

  • 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.

    PMID: 32299867RESULT

  • 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.

    PMID: 30705129RESULT

  • 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.

    PMID: 32783675RESULT

  • 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.

    PMID: 32556788RESULT

  • 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.

    PMID: 32422180RESULT

  • 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.

    PMID: 28990261RESULT

Results Point of Contact

Title
Dr. Jie Li
Organization
Rush University
jie_li@rush.edu
3125634643

Study Officials

  • Jie Li, PhD

    Rush University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 4, 2020

Study Start

December 23, 2020

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

December 21, 2022

Results First Posted

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Data are available upon reasonable request. Proposals should be directed to the corresponding author

Locations

US(1)