Blood Pressure Measured on the Arm With Different Layers of Clothing Versus on the Bare Arm in Patients at Grenoble Alpes University Hospital

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Blood pressure measurement
  Blood pressure measurements in addition to the standard care at patients admitted in the Emergency department as follow: * 3 Blood pressure measurements on bare arm serving as control in accordance with the guidelines. * 3 Blood pressure measurements over sleeves of varying thicknesses (thin, thick, and canyon)

Первичные конечные точки

• Differences between MAP measured over clothing and the average MAP measured on the bare arm [Срок оценки: 20 minutes]

Вторичные конечные точки (4)

• Differences between MAP measured between the various layers of clothing. [Срок оценки: 20 minutes]
• Error rate between groups with sleeves compared with the control group [Срок оценки: 20 minutes]
• Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group. [Срок оценки: 20 minutes]
• Difference of MAP measured between sleeves and control group in hypotensive patients [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07687771 · 38RC26.0150 · IDRCB :2026-A00880-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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