Blood Pressure Measured on the Arm With Different Layers of Clothing Versus on the Bare Arm in Patients at Grenoble Alpes University Hospital (PA-COUCHE)
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured at the arm over the patient's clothing when the patient cannot be undressed.
However there is no study proving the reliability of this measurement compared to measurement according to recommendations (blood pressure cuff).
This lack of proof could lead to misinterpretation when measurement conditions are not optimal.
연구 개요
상세 설명
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this observational study is to assess variations in blood pressure measurements based on the patient's clothing layers compared to the reference blood pressure measurement on the bare arm.
Once admitted to the Emergency Department (ED) the patient may be enrolled in the study according to the inclusion and non-inclusion criteria and after obtaining his consent.
Several series of blood pressure measurements are taken:
- A series taken on the bare arm as control
A series of measurements using sleeves of different thicknesses in random order.
3 types of sleeves will be used for which 3 measurements will be realised. A total of 12 measurements will be taken for each patient.
These measurements will be taken during the waiting period between the patient's initial assessment by the Triage Nurse upon arrival and their transfer to the emergency department assignment unit thereby ensuring that the patient's normal care is not delayed.
All measurements will be performed by the investigator using the same blood pressure monitorind device.
For each measurement systolic and diastolic blood pressure are collected and used to estimate a MAP.The average of the 3 values obtained are compared to determine whether there is a significat difference between the MAP measured over a layer of clothing (i.e a sleeve) and that measured on a bare arm .
Regarding the sleeves three sleeves thicknesses will be tested :
- a thin sleeve (base layer + technical fleece vest)
- a thick sleeve (thin layer + down jacket + windproof interface Gore - Tex type)
- a "canyon" type sleeve ( neoprene wetsuit)
These sleeves will be provided by the investigators and will remain the same throughout the study.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Prudence MABIALA MAKELE, PhD
- 전화번호: 0033476766784
- 이메일: pmabialamakele@chu-grenoble.fr
연구 연락처 백업
- 이름: JEREMY CHARLES, MD
- 전화번호: 0033476766784
- 이메일: PBordas@chu-grenoble.fr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- No objection by the subject to the study
- Affiliated to the French social security system (or equivalent)
Exclusion Criteria:
- Physical inability to collect BP at the admission in the emergency department (pain, arm wound)
- Technical inability to collect BP at the admission in the emergency department (incompatible size of the cuffs)
- Medical or surgical contraindication to repeated blood pressure measurement on both arms
- Patient who received antihypertensive treatment within the hour prior to measurements
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
- The patient already enrolled in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Patient admitted in the Emergency Department
Adult patient admitted in the Emergengy Department of Grenoble University Hospital will have several series of blood pressure measurement (12 in total) . Each patient will serve as case and control (i,e compared to himself). |
Blood pressure measurements in addition to the standard care at patients admitted in the Emergency department as follow:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Differences between MAP measured over clothing and the average MAP measured on the bare arm
기간: 20 minutes
|
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
|
20 minutes
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Differences between MAP measured between the various layers of clothing.
기간: 20 minutes
|
Differences between the mean of MAP measured between the various layers of clothing.
|
20 minutes
|
|
Error rate between groups with sleeves compared with the control group
기간: 20 minutes
|
Measurement error rate between groups with sleeves compared with the control group
|
20 minutes
|
|
Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group.
기간: 20 minutes
|
Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group.
|
20 minutes
|
|
Difference of MAP measured between sleeves and control group in hypotensive patients
기간: 24 hours
|
Difference in the mean of MAP measured between sleeves and control group in hypotensive patients
|
24 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: JEREMY CHARLES, MD, University Hospital, Grenoble
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
기타 연구 ID 번호
- 38RC26.0150
- IDRCB :2026-A00880-51 (기타 식별자: CPP ILE DE FRANCE X (French Ethics Committees))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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