A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery
Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of data collection using wearable postoperative biosensor patch.
SECONDARY OBJECTIVES:
I. To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively.
EXPLORATORY OBJECTIVES:
I. To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector.
II. To explore the accuracy of sweat-derived analyte concentrations relative to peripheral blood measurements (gold standard).
III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂).
IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard).
OUTLINE:
Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon dioxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.
After completion of study intervention, patients may be followed up for up to 1 year.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
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コンタクト：
- Kelly Mahuron
- 電話番号：89200 626-256-4673
- メール：kmahuron@coh.org
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主任研究者：
- Kelly Mahuron
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days
- Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use
- Ability to consent to the study procedures
Exclusion Criteria:
- Carbachol or pilocarpine allergy
- Adhesive/tape allergy
- Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices
- Pregnant women
- Children less than 18 years of age
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：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：Diagnostic (wearable biosensor patch)
Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon monoxide levels.
Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.
|
補助研究
補助研究
補助研究
Undergo sweat sample collection
他の名前：
Wear biosensor patch
|
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 |
|---|---|---|
|
Proportion of successful sweat collections (feasibility)
時間枠：Up to 1 year
|
A successful collection will be defined by patch application with data successfully recorded and sent to the database.
Examples of failed collections include, but are not limited to, a patch falling off before data collection can occur or a patch failing to collect and send data to the database.
The number of successful collections will be reported as a proportion of the total number of attempted applications.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
Given the small sample, two-sided 95 percent exact (Clopper-Pearson) confidence intervals will be provided for proportions.
In addition to the overall success rate, the success rates for each type of patch (intraoperative and postoperative) will be described.
All causes of failure (including unknown causes) will be reported.
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Up to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of the intervention
時間枠：Up to 1 year
|
Assessed using Acceptability of Intervention Measure (AIM) scores and qualitative data analysis of patient exit interviews.
Scores will be summarized descriptively.
Exit interviews will be conducted to explore subjective experience with the biosensor patch.
Topics will include comfort/discomfort while wearing the patch, comfort/discomfort during application and removal, and open-ended feedback.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
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Up to 1 year
|
|
Incidence of treatment related adverse events related to biosensor use
時間枠：Up to 1 year
|
Safety will be evaluated based on the incidence of treatment-emergent adverse events deemed definitely, probably, or possibly related to the biosensor device.
Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
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Up to 1 year
|
|
Processes and resources needed to deploy the wearable biosensor patches postoperatively
時間枠：Up to 1 year
|
Processes and resources needed to deploy the biosensor patches will be assessed through one focus group.
Topics will include: approximate time to setting up the patch for patients and applying them, barriers and facilitators in deploying the patches, and open-ended feedback.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
|
Up to 1 year
|
協力者と研究者
捜査官
- 主任研究者：Kelly Mahuron、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 25132 (その他の識別子：City of Hope Medical Center)
- P30CA033572 (米国 NIH グラント/契約)
- NCI-2026-03601 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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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