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

• ClinicalTrials.gov Identifier: NCT04654754
• Recruitment Status: Completed
• First Posted: December 4, 2020
• Results First Posted: November 22, 2022
• Last Update Posted: December 21, 2022
• Sponsor: Jie Li
• Information provided by (Responsible Party): Jie Li, Rush University Medical Center

Tracking Information

• First Submitted Date: November 25, 2020
• First Posted Date: December 4, 2020
• Results First Submitted Date: August 17, 2022
• Results First Posted Date: November 22, 2022
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: December 23, 2020
• Actual Primary Completion Date: July 16, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2022)

• 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

Original Primary Outcome Measures (submitted: December 2, 2020)

• aerosol particle concentrations at 1 foot away from patient [ Time Frame: 5 minutes after using the device ]
  aerosol particle concentrations at 1 foot away from patient
• aerosol particle concentrations at 3 feet away from patient [ Time Frame: 5 minutes after using the device ]
  aerosol particle concentrations at 3 feet away from patient

Current Secondary Outcome Measures (submitted: September 15, 2022)

Patient Comfort With Different Oxygen Devices [ Time Frame: 5 minutes after using the device ]

Patients would scale their comfort on a 5-point Likert scale, 1 was the most uncomfortable, and 5 was the most comfortable.

Original Secondary Outcome Measures (submitted: December 2, 2020)

patient comfort with different oxygen devices [ Time Frame: 5 minutes after using the device ]

patients would scale their comfort at a 5-point Likert scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy
• Official Title: Aerosol Particle Concentrations Among Different Oxygen Devices for Spontaneous Breathing Patients With Tracheostomy: a Randomized Cross-over Trial
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:

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

Primary Purpose: Other

• Condition: Transmission, Patient-Professional

Intervention

Device: 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.

Other Name: Airvo2, Fisher & Paykel Healthcare Ltd

Study Arms

• Experimental: 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.
  Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
• Active Comparator: 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.
  Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
• Placebo Comparator: Venturi-adapter with trach collar
  This device did not provide any humidification but only oxygen
  Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
• Experimental: 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
  Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter
• Experimental: 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
  Intervention: Device: high-flow high humidity oxygen device with tracheostomy adapter

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 17, 2020): 12
• Original Estimated Enrollment (submitted: December 2, 2020): 10
• Actual Study Completion Date: July 16, 2021
• Actual Primary Completion Date: July 16, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04654754
• Other Study ID Numbers: HFOT-trach-aerosol
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Data are available upon reasonable request. Proposals should be directed to the corresponding author

• Current Responsible Party: Jie Li, Rush University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Jie Li
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jie Li, PhD; Rush University

• PRS Account: Rush University Medical Center
• Verification Date: November 2022