Evaluation of Free Air Portable Air Powered Respirator
Evaluation of Free Air Portable Air Powered Respirator System for Prevention of Influenza Transmission
調査の概要
詳細な説明
Airborne transmission represents one of the most rapidly spreading and least understood dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) decontamination of the exposed areas and surfaces, and 3) isolation and barrier precautions such as face masks. Unfortunately, evidence of the efficacy of currently recommended barrier precautions is currently lacking.
Attempts to validate the effectiveness of personal protective equipment are limited to in vitro experiments with mannequin heads. This human exposure study will provide a much more accurate life-like exposure scenario. The use of live attenuated influenza virus vaccine has been proven to be safe.
Objectives: Evaluate the Free Air Portable Air Powered Respirator (PAPR) versus an N95 face mask for preventing the airborne cross-transmission of aerosolized influenza in human participants.
Methods: Participants will be randomized to one of two arms: a) N95 respirator, or b) Free Air PAPR System. The primary outcome will be the rate of the transmission for the 2 study groups, so a nasal and nasopharyngeal swab will be performed immediately following the exposure.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18-49 years of age
- Employee or student at Wake Forest University School of Medicine and Wake Forest University
Exclusion Criteria:
- 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
- Treatment with nasal decongestants, nasal antibiotic and/or steroid preparations will not be allowed
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:N95 Respirator
Participants in this arm will wear an N95 respirator and safety goggles during Live Attenuated Influenza Vaccine exposure.
|
The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.
|
|
実験的:Free Air Portable Air Powered Respirator
Participants in this arm will wear a Free Air PAPR and safety goggles during Live Attenuated Influenza Vaccine exposure.
|
The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nasal Swabs
時間枠:Immediately following Live Attenuated Influenza Vaccine exposure
|
A nasal swab will be performed immediately following the exposure.
|
Immediately following Live Attenuated Influenza Vaccine exposure
|
|
Nasopharyngeal swabs
時間枠:Immediately following Live Attenuated Influenza Vaccine exposure
|
A nasopharyngeal swab will be performed immediately following the exposure.
|
Immediately following Live Attenuated Influenza Vaccine exposure
|
協力者と研究者
協力者
捜査官
- 主任研究者:Werner Bischoff, MD, PhD、Wake Forest University Health Sciences
出版物と役立つリンク
一般刊行物
- 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.
- 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. Erratum In: N Engl J Med. 2012 Feb 23;366(8):771.
- 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/
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
便利なリンク
- CDC Guidelines and Recommendations Prevention Strategies for Seasonal Influenza in Healthcare Settings September 20, 2010. (Accessed January 28, 2011)
- 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)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00031388
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
N95 Respiratorの臨床試験
-
Johns Hopkins UniversityChildren's Hospital Colorado; US Department of Veterans Affairs; Centers for Disease Control and... と他の協力者完了
-
Brigham and Women's Hospital引きこもった
-
University Hospitals Cleveland Medical CenterPeking University; University of Michigan完了
-
University of North Carolina, Chapel HillEnvironmental Protection Agency (EPA)完了
-
McMaster UniversityUniversity of Alberta完了