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
2 other identifiers
observational
161
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
July 7, 2026
June 1, 2026
5 months
June 30, 2026
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Differences between MAP measured between the various layers of clothing.
20 minutes
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.
20 minutes
Difference of MAP measured between sleeves and control group in hypotensive patients
24 hours
Study Arms (1)
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).
Interventions
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)
Eligibility Criteria
patient admitted in the Emergency department of Grenoble University Hospital
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
JEREMY CHARLES, MD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2026
First Posted
July 7, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
July 7, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the time of publication
- 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
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.