Validation of a Connected Patch, an Alternative to Conventional Monitoring
調査の概要
詳細な説明
When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.
The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.
One of the crucial issues is therefore the speed of the alarm and its reliability.
The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.
The connected patch used in this research is the Scaléo Médical company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.
The objective of this research is therefore to validate Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Suresnes、フランス、92150
- Hôpital Foch
-
-
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:
- patient over 18 and under 85 years of age
- patient requiring general anesthesia for extra-thoracic surgery
- the patient's position during the operation is in supine position only
- patient affiliated to or benefiting from social security, excluding State Medical Assistance
- patient with written consent
Exclusion Criteria:
- pregnant or breastfeeding patients
- patients known to have severe skin reactions to adhésives
- patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
- patients deprived of their liberty or under guardianship
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:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:接続されたパッチの検証
|
接続されたパッチを使用して、血圧、心拍数、呼吸数、動脈血酸素飽和度、体温を収集します
|
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 |
---|---|---|
Concordance of blood pressure value measured by 2 different devices after surgery
時間枠:36 hours maximum after the surgery
|
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
|
36 hours maximum after the surgery
|
Concordance of heart rate value measured by 2 different devices after surgery
時間枠:36 hours maximum after the surgery
|
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
|
36 hours maximum after the surgery
|
Concordance of respiratory rate value measured by 2 different devices after surgery
時間枠:36 hours maximum after the surgery
|
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
|
36 hours maximum after the surgery
|
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
時間枠:36 hours maximum after the surgery
|
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
|
36 hours maximum after the surgery
|
Concordance of temperature value measured by 2 different devices after surgery
時間枠:36 hours maximum after the surgery
|
Comparison between temperature measured by conventional medical monitoring device and by connected patch
|
36 hours maximum after the surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Concordance of blood pressure value measured by 2 different devices during surgery
時間枠:During surgery
|
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Concordance of heart rate value measured by 2 different devices during surgery
時間枠:During surgery
|
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Concordance of respiratory rate value measured by 2 different devices during surgery
時間枠:During surgery
|
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Concordance of arterial oxygen saturation value measured by 2 different devices during surgery
時間枠:During surgery
|
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Concordance of temperature value measured by 2 different devices during surgery
時間枠:During surgery
|
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Blood pressure artifact
時間枠:From surgery to 36 hours maximum after the surgery
|
Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
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From surgery to 36 hours maximum after the surgery
|
Heart rate artifact
時間枠:From surgery to 36 hours maximum after the surgery
|
Value of heart rate will be considered as artifact if value < 40 or > 140
|
From surgery to 36 hours maximum after the surgery
|
Respiratory rate artifact
時間枠:From surgery to 36 hours maximum after the surgery
|
Value of respiratory rate will be considered as artifact if value < 8 or > 36
|
From surgery to 36 hours maximum after the surgery
|
Arterial oxygen saturation artifact
時間枠:From surgery to 36 hours maximum after the surgery
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Value of arterial oxygen saturation will be considered as artifact if value < 85 %
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From surgery to 36 hours maximum after the surgery
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Acceptability of connected patch: numerical scale
時間枠:During the surgery and through study completion
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Evaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
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During the surgery and through study completion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Morgan Le Guen、Hôpital Foch
研究記録日
主要日程の研究
研究開始 (予想される)
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 (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
- 2017055F
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
米国で製造され、米国から輸出された製品。
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パッチの検証の臨床試験
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Yonsei University募集
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Population Health Research InstituteCanadian Institutes of Health Research (CIHR); University of Leipzig; Heart and Stroke Foundation... と他の協力者完了