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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Prudence MABIALA MAKELE, PhD
- 电话号码:0033476766784
- 邮箱:pmabialamakele@chu-grenoble.fr
研究联系人备份
- 姓名:JEREMY CHARLES, MD
- 电话号码:0033476766784
- 邮箱:PBordas@chu-grenoble.fr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Differences between MAP measured over clothing and the average MAP measured on the bare arm
大体时间:20 minutes
|
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
|
20 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Differences between MAP measured between the various layers of clothing.
大体时间: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
大体时间: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.
大体时间: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
大体时间:24 hours
|
Difference in the mean of MAP measured between sleeves and control group in hypotensive patients
|
24 hours
|
合作者和调查者
调查人员
- 首席研究员:JEREMY CHARLES, MD、University Hospital, Grenoble
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 38RC26.0150
- IDRCB :2026-A00880-51 (其他标识符:CPP ILE DE FRANCE X (French Ethics Committees))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.