Evaluation of Free Air Portable Air Powered Respirator

NCT02487147 | Completed

• 1 other identifier: IRB00031388
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR) system versus a N95 mask in preventing nasal detection of influenza following an exposure. The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95 respirator at interrupting the exposure of the study participants to aerosolized influenza virus particles.

Conditions

Influenza

Keywords

Live Attenuated Influenza Vaccine (FluMist); Free Air Portable Air Powered Respirator; N95 Respirator; Personal Protective Equipment; Viral Transmission

Outcome Measures

Primary Outcomes (2)

• Nasal Swabs

  A nasal swab will be performed immediately following the exposure.

  Immediately following Live Attenuated Influenza Vaccine exposure

• Nasopharyngeal swabs

  A nasopharyngeal swab will be performed immediately following the exposure.

  Immediately following Live Attenuated Influenza Vaccine exposure

Study Arms (2)

N95 Respirator

ACTIVE COMPARATOR

Participants in this arm will wear an N95 respirator and safety goggles during Live Attenuated Influenza Vaccine exposure.

Other: N95 Respirator

Free Air Portable Air Powered Respirator

EXPERIMENTAL

Participants in this arm will wear a Free Air PAPR and safety goggles during Live Attenuated Influenza Vaccine exposure.

Other: Free Air Portable Air Powered Respirator

Interventions

Free Air Portable Air Powered Respirator OTHER

The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.

Also known as: Free Air PAPR

Free Air Portable Air Powered Respirator

N95 Respirator OTHER

The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.

N95 Respirator

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-49 years of age
• Employee or student at Wake Forest University School of Medicine and Wake Forest University

You may not qualify if:

• Respiratory tract disorders and other chronic diseases, and medical conditions and treatments which are contraindications to mask usage
• Severe claustrophobia or inability to tolerate masks
• Contraindications to FluMist:
• Children younger than 18 years; proposed age range is 18-49
• Adults 50 years and older; proposed age range is 18-49
• People who have received the live attenuated influenza vaccine within 3 weeks of the exposure sessions
• People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine
• People who are allergic to eggs
• Pregnant women
• People with weakened immune systems (immunosuppression)
• People who have taken influenza antiviral drugs within the previous 48 hours
• People who care for severely immunocompromised persons who require a protective environment (or otherwise avoid contact with those persons for 7 days after getting the nasal spray vaccine)
• People of any age with asthma might be at increased risk for wheezing after getting the nasal spray vaccine
• The safety of the nasal spray vaccine has not been established in people with underlying medical conditions that place them at high risk of serious flu complications. This includes children and adults who have lung disease, heart disease (except isolated hypertension), kidney disease (like diabetes), kidney or liver disorders, neurologic/neuromuscular, or metabolic disorders. Moderate or severe acute illness with or without fever is a general precaution for vaccination
• Guillain-Barre Syndrome (GBS) within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of all influenza vaccines

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Free Air: collaborator

Study Sites (1)

Wake Forest School Of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (18)

• Miller MA, Viboud C, Balinska M, Simonsen L. The signature features of influenza pandemics--implications for policy. N Engl J Med. 2009 Jun 18;360(25):2595-8. doi: 10.1056/NEJMp0903906. Epub 2009 May 7. No abstract available.

  PMID: 19423872 BACKGROUND

• Institute of Medicine (US) Committee on Personal Protective Equipment for Healthcare Personnel to Prevent Transmission of Pandemic Influenza and Other Viral Respiratory Infections: Current Research Issues; Larson EL, Liverman CT, editors. Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel: Update 2010. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209584/

  PMID: 24983058 BACKGROUND

• Brankston G, Gitterman L, Hirji Z, Lemieux C, Gardam M. Transmission of influenza A in human beings. Lancet Infect Dis. 2007 Apr;7(4):257-65. doi: 10.1016/S1473-3099(07)70029-4.

  PMID: 17376383 BACKGROUND

• Bischoff WE, Bassetti S, Bassetti-Wyss BA, Wallis ML, Tucker BK, Reboussin BA, D'Agostino RB Jr, Pfaller MA, Gwaltney JM Jr, Sherertz RJ. Airborne dispersal as a novel transmission route of coagulase-negative staphylococci: interaction between coagulase-negative staphylococci and rhinovirus infection. Infect Control Hosp Epidemiol. 2004 Jun;25(6):504-11. doi: 10.1086/502430.

  PMID: 15242200 BACKGROUND

• Bischoff WE, Tucker BK, Wallis ML, Reboussin BA, Pfaller MA, Hayden FG, Sherertz RJ. Preventing the airborne spread of Staphylococcus aureus by persons with the common cold: effect of surgical scrubs, gowns, and masks. Infect Control Hosp Epidemiol. 2007 Oct;28(10):1148-54. doi: 10.1086/520734. Epub 2007 Aug 29.

  PMID: 17828691 BACKGROUND

• Gwaltney JM, Hendley JO. Respiratory transmission. In: Epidemiologic methods for the study of infectious diseases. (p.213-227) Thomas JC, Weber DJ (eds). Oxford University Press. 2001, New York, New York.

  BACKGROUND

• Bischoff WE. Novel Technique to Study Live Influenza and Common Cold Virus in Mono-Dispersed Aerosols. 49th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, K-1615a, Sept. 12-15, 2009

  BACKGROUND

• Bischoff WE. Transmission route of rhinovirus type 39 in a monodispersed airborne aerosol. Infect Control Hosp Epidemiol. 2010 Aug;31(8):857-9. doi: 10.1086/655022.

  PMID: 20569111 BACKGROUND

• Murayama S, Kawai R, Hirabuki N, Miura T, Mitomo M, Kozuka T, Usio Y. [Intra-arterial ACNU chemotherapy of malignant glioma]. Nihon Igaku Hoshasen Gakkai Zasshi. 1988 Feb 25;48(2):144-53. No abstract available. Japanese.

  PMID: 3164472 BACKGROUND

• Bischoff WE, Swett K, Leng I, Peters TR. Exposure to influenza virus aerosols during routine patient care. J Infect Dis. 2013 Apr;207(7):1037-46. doi: 10.1093/infdis/jis773. Epub 2013 Jan 30.

  PMID: 23372182 BACKGROUND

• Hayden FG, Albrecht JK, Kaiser DL, Gwaltney JM Jr. Prevention of natural colds by contact prophylaxis with intranasal alpha 2-interferon. N Engl J Med. 1986 Jan 9;314(2):71-5. doi: 10.1056/NEJM198601093140202.

  PMID: 3001519 BACKGROUND

• Ford CR, Peterson DE, Mitchell CR. An appraisal of the role of surgical face masks. Am J Surg. 1967 Jun;113(6):787-90. doi: 10.1016/0002-9610(67)90348-0. No abstract available.

  PMID: 6023917 BACKGROUND

• Ha'eri GB, Wiley AM. The efficacy of standard surgical face masks: an investigation using "tracer particles". Clin Orthop Relat Res. 1980 May;(148):160-2.

  PMID: 7379387 BACKGROUND

• Mitchell NJ, Hunt S. Surgical face masks in modern operating rooms--a costly and unnecessary ritual? J Hosp Infect. 1991 Jul;18(3):239-42. doi: 10.1016/0195-6701(91)90148-2.

  PMID: 1680906 BACKGROUND

• Huang C, Willeke K, Qian Y, Grinshpun S, Ulevicius V. Method for measuring the spatial variability of aerosol penetration through respirator filters. Am Ind Hyg Assoc J. 1998 Jul;59(7):461-5. doi: 10.1080/15428119891010208.

  PMID: 9697293 BACKGROUND

• Qian Y, Willeke K, Grinshpun SA, Donnelly J, Coffey CC. Performance of N95 respirators: filtration efficiency for airborne microbial and inert particles. Am Ind Hyg Assoc J. 1998 Feb;59(2):128-32. doi: 10.1080/15428119891010389.

  PMID: 9487666 BACKGROUND

• Treanor JJ, Kotloff K, Betts RF, Belshe R, Newman F, Iacuzio D, Wittes J, Bryant M. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine. 1999 Dec 10;18(9-10):899-906. doi: 10.1016/s0264-410x(99)00334-5.

  PMID: 10580204 BACKGROUND

• The Rainbow Passage, a public domain text, can be found on page 127 of the 2nd edition of Grant Fairbanks' Voice and Articulation Drillbook. New York: Harper & Row

  BACKGROUND

Related Links

• American National Standards Institute (ANSI)/ American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) 52.2 Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size. (Accessed Dec1,2011)

MeSH Terms

Conditions

Influenza, Human

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Werner Bischoff, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 1, 2015
• Study Start: November 14, 2016
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: March 4, 2022

Record last verified: 2018-10

Locations

US (1)