Blood Pressure Measured on the Arm : Bare Arm Versus a Speleological Suit Sleeve in Patients From Grenoble Alpes University Hospital (PA- COUCHE Speleo)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a bare arm
研究概览
简要总结
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured on the arm over the clothes of the patient, who cannot be undressed.
There is no study proving the reliability of this measurement compared to measurement according to the recommendations (blood pressure cuff).
This lack of proof could lead to misinterpretation when measurement conditions are not optimal.
详细描述
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this study is to assess variations in blood pressure measurements based on the layer of the patient's technical caving clothing 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 :
- 3 measurements of blood pressure on a bare arm being the reference value corresponding to the recommendations on taking blood pressure
- 3 measurements of blood pressure over a speleological (caving) suit sleeve
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- •National health insurance coverage or an equivalent form of coverage
排除标准
- •Physical or technical inability to collect BP upon the patient's admission at ED (wounds or trauma to the arms)
- •Technical impossibility to set up the tested sleeve (incompatible arm size)
- •Patient with a medical contraindication to repeated blood pressure measurements on both arms
- •Patient who received antihypertensive treatment within the hour prior to measurements
- •Staff with hierarchical family or friendly ties to the principal investigator
- •Inability to provide informed consent because of impaired communication in French
- •Persons covered by Articles L1121-5 to L1121-8 of the Public Health Code
- •The patient already enrolled in the study
- •Objection by the subject to the study
研究组 & 干预措施
Patient admitted in the Emergency Department
Patient admitted in the Emergency Department Adult patient admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement (6 in total).
Each patient will serve as case and control (i, e compared to himself).
干预措施: Blood pressure measurement (Other)
结局指标
主要结局
Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a bare arm
时间窗: 20 minutes
Difference between the mean of the Mean Arterial Pressures (MAP) measured with a sleeve and the mean of the MAP measured on a bare arm.
次要结局
- Difference between the mean of the SBP measurements taken over a speleological (caving) suit sleeve compared to the bare arm(20 minutes)
- Difference between the mean of the MAP measurements taken with a sleeve and the mean of the MAP measurements taken on the bare arm in a subgroup of hypotensive patients(24 hours)