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Validation of a Connected Patch, an Alternative to Conventional Monitoring

2020년 2월 3일 업데이트: Hopital Foch
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

연구 개요

상태

빼는

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Suresnes, 프랑스, 92150
        • Hôpital Foch

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 연결된 패치 검증
연결된 패치를 사용하여 혈압, 심박수, 호흡수, 동맥 산소포화도 및 온도를 수집합니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Concordance of blood pressure value measured by 2 different devices after surgery
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Concordance of blood pressure value measured by 2 different devices during surgery
기간: 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
기간: 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
기간: 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
기간: 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
기간: During surgery
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
During surgery
Blood pressure artifact
기간: 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
From surgery to 36 hours maximum after the surgery
Heart rate artifact
기간: 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
기간: 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
기간: From surgery to 36 hours maximum after the surgery
Value of arterial oxygen saturation will be considered as artifact if value < 85 %
From surgery to 36 hours maximum after the surgery
Acceptability of connected patch: numerical scale
기간: During the surgery and through study completion
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
During the surgery and through study completion

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Morgan Le Guen, Hôpital Foch

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2020년 1월 1일

기본 완료 (예상)

2020년 9월 4일

연구 완료 (예상)

2020년 9월 4일

연구 등록 날짜

최초 제출

2019년 8월 6일

QC 기준을 충족하는 최초 제출

2019년 8월 9일

처음 게시됨 (실제)

2019년 8월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 2월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 2월 3일

마지막으로 확인됨

2019년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2017055F

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

패치 검증에 대한 임상 시험

3
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