Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) (STRIPE-3)
Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE
Personal protective equipment (PPE) is vital to ensuring staff safety during the COVID-19 pandemic. Properly designed, formal PPE (fPPE) is in increasingly short supply, and a series of improvised PPE (iPPE) designs have been widely circulated on the internet, particularly on social media. Groups have started to publicise these devices through websites and the lay press. Some are even using crowd-funding to finance the purchase of these systems with the intention of supplying NHS workers in place of approved systems.
It is not clear what degree of testing these systems have undergone. The investigators are already planning trials formally investigating the quality of seal offered by these improvised systems. Currently the team are investigating a designed based on a modified snorkel mask (STRIPE-1). In the current study the investigators wish to extend this investigation to consider the atmosphere within the mask.
This is an important question, as modifications to the snorkel design have changed the way gases mix within the system. This might increase the risk that the user will rebreathe expired gases, which will dilute the amount of oxygen available to them, and increase the carbon dioxide levels to which they are exposed. At extreme deviations, these might pose a potential health hazard over and above the risks posed by COVID-19 exposure via a poor mask seal.
This study will therefore recruit a convenience sample of 10, and request they wear two masks sequentially. These masks will comprise: a formally designed and tested commercial FFP3 mask, and one design of improvised PPE, based on the snorkel design available on the internet.
Each mask will be worn for a total of 40 minutes. In the first 20 minutes measurements will be taken with the user at rest. In the second 20 minutes measurements will be taken while the user undertakes light exercise.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
London、イギリス、SE1 7EH
- St Thomas' Hospital
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Willing and able to give informed consent for participation in the study
- Healthy adults, male or female, aged 18 or more
- Clean-shaven at the point of testing
- Willing and able to undertake 20 minutes of light exercise e.g. stepping
Exclusion Criteria:
- They have facial hair that would disrupt the seals of the mask
- They have significant facial injuries or malformations that preclude a good mask seal
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
- 観測モデル:ケースクロスオーバー
- 時間の展望:見込みのある
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 |
---|---|---|
Oxygen concentration while wearing purpose-designed mask
時間枠:40 minutes starting from intervention (donning of mask)
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5-minute measurement of oxygen concentration in inspired and expired gases
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40 minutes starting from intervention (donning of mask)
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Oxygen concentration while wearing improvised snorkel-based mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5-minute measurement of oxygen concentration in inspired and expired gases
|
40 minutes starting from intervention (donning of mask)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Carbon dioxide concentration while wearing purpose-designed mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of carbon dioxide concentration in inspired and expired gases
|
40 minutes starting from intervention (donning of mask)
|
Carbon dioxide concentration while wearing improvised snorkel-based mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of carbon dioxide concentration in inspired and expired gases
|
40 minutes starting from intervention (donning of mask)
|
Heart rate while wearing purpose-designed mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of heart rate
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40 minutes starting from intervention (donning of mask)
|
Heart rate while wearing improvised snorkel-based mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of heart rate
|
40 minutes starting from intervention (donning of mask)
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Respiratory rate while wearing purpose-designed mask
時間枠:40 minutes starting from intervention (donning of mask)
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5 minute measurement of respiratory rate
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40 minutes starting from intervention (donning of mask)
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Respiratory rate while wearing improvised snorkel-based mask
時間枠:40 minutes starting from intervention (donning of mask)
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5 minute measurement of respiratory rate
|
40 minutes starting from intervention (donning of mask)
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Oxygen saturation while wearing purpose-designed mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of oxygen saturation
|
40 minutes starting from intervention (donning of mask)
|
Oxygen saturation while wearing improvised snorkel-based mask
時間枠:40 minutes starting from intervention (donning of mask)
|
5 minute measurement of oxygen saturation
|
40 minutes starting from intervention (donning of mask)
|
協力者と研究者
捜査官
- スタディチェア:Paul R Greig, MBChB、Guy's and St Thomas' NHS Foundation Trust
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 (実際)
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
その他の研究ID番号
- TAP_PRG_21_04_2020_2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
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