The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry
End-tidal Carbon Dioxide Measurements in Adults and Children Wearing Surgical Masks
An Interventional Study is planned with the primary purpose of screening for changes in end-tidal carbon dioxide (ETCO2), inspired carbon dioxide (ICO2), and other vital signs that may develop after donning a disposable surgical mask.
Measurements will be taken and recorded during a 5-minute control period without a mask, recording non-invasive ETCO2 and ICO2 levels by way of a nasal cannula (NC), oxygen saturation (SpO2), breaths per minute (RR), and heart rate (HR) via anesthesia equipment. This will be followed by a 15-minute intervention of wearing a disposable surgical mask and repeating measurements of ETCO2, ICO2, SpO2, RR, and HR, recorded each minute.
Data will be collected from adults and children as young as 2 years of age. Age groups will include children aged 2-14 and adults aged 18 to 80, as described in the details of the research protocol. Parents and their children are invited to participate together.
調査の概要
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
-
-
Missouri
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Springfield、Missouri、アメリカ、65897-0027
- Missouri State University
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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
説明
Inclusion Criteria:
- Good health
- Aged 2 - 14 years (inclusive) or 18 - 80 years (inclusive)
Exclusion Criteria:
- Significant cardiopulmonary diseases
- Intolerance to wearing nasal canula
- Intolerance to wearing a surgical mask
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：ふるい分け
- 割り当て：なし
- 介入モデル：順次割り当て
- 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 |
|---|---|
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実験的：Effects of donning a disposable surgical mask
Participants will be observed and monitored without wearing a mask for a 5-minute control period. Measurements will include End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute without a mask x 5 minutes. After 5 minutes, all study subjects will don the same model of disposable surgical mask. The same measurements will be taken, including End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute with a mask x 15 minutes. |
Physiologic vital signs will be monitored every minute for 5 minutes without a mask, followed by every minute for 15 minutes with a surgical mask.
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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 |
|---|---|---|
|
Potential Change in End Tidal CO2 level
時間枠：End tidal CO2 levels after 5 minutes without a mask will be compared to End Tidal CO2 levels after 15 minutes wearing a disposable surgical mask
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measurement of End Tidal CO2 by way of nasal cannula
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End tidal CO2 levels after 5 minutes without a mask will be compared to End Tidal CO2 levels after 15 minutes wearing a disposable surgical mask
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Potential change in Inspired CO2 level
時間枠：Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask
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measurement of inspired CO2 by way of nasal cannula
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Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask
|
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Potential change in oxygen saturation
時間枠：Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask
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measurement of oxygen saturation by way of noninvasive pulse oximetry
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Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask
|
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Potential change in respiratory rate measured in breaths per minute
時間枠：Respiratory rate after 5 minutes without a mask will be compared to respiratory rate after 15 minutes wearing a disposable surgical mask
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measurement of breaths per minute
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Respiratory rate after 5 minutes without a mask will be compared to respiratory rate after 15 minutes wearing a disposable surgical mask
|
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Potential change in Heart Rate
時間枠：Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask
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measurement of heart rate in beats per minute
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Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask
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協力者と研究者
スポンサー
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
その他の研究ID番号
- CT-2021-01
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。