The Effect of Heat on Blood and Oxygen Flow Readings Part 2
This is the second part of a research study in order to determine if using a specialized pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD), vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled. SaO2 and pulse readings are important to maintain patient stability during diagnostic testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and pulse are important to monitor in order to be able to compensate for any decrease in patient oxygen saturations during hemodynamic monitoring.
The primary aim of this study is to determine if using a specialized pulse oximetry probe with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to readings obtained from an arterial blood gas.
The hypothesis is using a specialized pulse oximetry probe with external heat pack will help obtain more accurate pulse oximetry readings consistent with values obtained with an arterial blood gas.
調査の概要
状態
詳細な説明
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
-
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15240
- VA Pittsburgh Healthcare System
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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:
- Age > 18 years
- Able to give informed consent
- Patients must be able to read and understand English.
- Patients scheduled to enter the VA Pittsburgh Healthcare System catheterization lab
Arm 2 of the study:
1. The PI will determine if patients have poor circulation due to obstruction of the large arteries in their arms and legs (peripheral vascular disease (PVD), narrowing of their blood vessels (vasoconstriction), or extremities (arms, legs, etc) that are at least 3 degrees Fahrenheit below their normal body temperature. If patients do have any of the following they will be considered for arm 2. If they do not they will be considered for arm 1.
Exclusion Criteria:
In addition to the exclusions mentioned above, patients with the following conditions will be excluded from the trial:
1. Inability or unwillingness to sign informed consent with free will and sound mind, as determined by a score of <11 on the Evaluation to Sign Consent Form.
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：診断
- 割り当て：非ランダム化
- 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 |
|---|---|
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アクティブコンパレータ：Non-Healthy Subjects arm
Subjects in this arm will have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack
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Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
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アクティブコンパレータ：Healthy Subjects Arm
Subjects who do not have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities will be considered healthy subjects and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack.
|
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
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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 |
時間枠 |
|---|---|
|
Pulse Oximetry
時間枠：measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Arterial Blood Gas
時間枠：measured once - day 1
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measured once - day 1
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Temperature
時間枠：measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
|
協力者と研究者
捜査官
- 主任研究者：Catherine Abee, CRT、VA Pittsburgh Healthcare System
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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。