Blood Pressure Measured on the Arm : Bare Arm Versus a Speleological Suit Sleeve in Patients From Grenoble Alpes University Hospital

NCT07843160 | Not Yet Recruiting

• 2 other identifiers: 38RC26.0264IDRCB :2026-A01612-49
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Keywords

Blood Pressure measurement; Bar Arm; Speleological suit sleeve

Outcome Measures

Primary Outcomes (1)

• Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a bare arm

  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.

  20 minutes

Secondary Outcomes (2)

• 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

Study Arms (1)

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).

Other: Blood pressure measurement

Interventions

Blood pressure measurement OTHER

Blood pressure measurements in addition to the standard care at patients admitted in the Emergency department as follow : * 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

Patient admitted in the Emergency Department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (male and female) admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement .

You may qualify if:

• Patient over 18 years admitted to the emergency department of Grenoble University Hospital
• National health insurance coverage or an equivalent form of coverage

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, Autre, France

Location

Study Officials

• JEREMY CHARLES, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• MAEL LEPOUPON, MD

  University Hospital, Grenoble

  STUDY DIRECTOR

Central Study Contacts

MAEL LEPOUPON, MD

CONTACT

0033476766784; mlepoupon@chu-grenoble.fr

Prudence MABIALA MAKELE, PhD

CONTACT

0033476766784; pmabialamakele@chu-grenoble.fr

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: September 16, 2026
• First Posted: September 25, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

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.

Locations

FR (1)