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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Blood pressure measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 161

Contacts and Locations

• Study Contact: Name: Prudence MABIALA MAKELE, PhD; Phone Number: 0033476766784; Email: pmabialamakele@chu-grenoble.fr
• Study Contact Backup: Name: JEREMY CHARLES, MD; Phone Number: 0033476766784; Email: PBordas@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient admitted in the Emergency department of Grenoble University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between MAP measured over clothing and the average MAP measured on the bare arm	Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between MAP measured between the various layers of clothing.	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	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.	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	Difference in the mean of MAP measured between sleeves and control group in hypotensive patients	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: JEREMY CHARLES, MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sleeve; Blood Pressure measurement; Bar Arm
• Other Study ID Numbers: 38RC26.0150; IDRCB :2026-A00880-51 (Other Identifier: CPP ILE DE FRANCE X (French Ethics Committees))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame: At the time of publication
• IPD Sharing Access Criteria: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4th, 2002
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No