Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
調査の概要
詳細な説明
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.
Trial goals
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Kfar Saba、イスラエル、4428164
- Meir health center
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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:
- Patients referred to an Stress Echocardiography test for cardiac diagnostics
- Male and Female
- Between 18 to 90 years old
Exclusion Criteria:
- Under the age of 18 or over 90 years old
- Patients in Shock
- Patients with Moderate or Severe valvular disease
- Patients with severe sepsis
- Inadequate jurisprudence patients
- Patients supported by Amines
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
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 |
---|---|---|
Cardiac Output
時間枠:Change from Baseline in Cardiac Output at 30 minutes
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Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
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Change from Baseline in Cardiac Output at 30 minutes
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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 |
---|---|---|
Blood Pressure
時間枠:Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
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Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
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Heart rate
時間枠:Change from Baseline in heart rate at 30 minutes
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Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test
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Change from Baseline in heart rate at 30 minutes
|
協力者と研究者
捜査官
- 主任研究者:Yoram Neuman, MD、Meir Health Facility
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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。
低心拍出量の臨床試験
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityまだ募集していません
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Daiichi Sankyo募集
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Daiichi Sankyo完了
Pulse Oximeter CMS50FW (Contec Medical)の臨床試験
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Institut de Recherche en Sciences de la Sante,...募集