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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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연락하다:
- Kelly Mahuron
- 전화번호: 89200 626-256-4673
- 이메일: kmahuron@coh.org
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수석 연구원:
- Kelly Mahuron
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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보조 연구
보조 연구
보조 연구
Undergo sweat sample collection
다른 이름들:
Wear biosensor patch
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of successful sweat collections (feasibility)
기간: Up to 1 year
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability of the intervention
기간: Up to 1 year
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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
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Incidence of treatment related adverse events related to biosensor use
기간: Up to 1 year
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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
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Processes and resources needed to deploy the wearable biosensor patches postoperatively
기간: Up to 1 year
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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.
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Up to 1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kelly Mahuron, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25132 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-03601 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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