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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)

30. juni 2026 opdateret af: University Hospital, Grenoble

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

161

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patient admitted in the Emergency department of Grenoble University Hospital

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).

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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences between MAP measured over clothing and the average MAP measured on the bare arm
Tidsramme: 20 minutes
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
20 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences between MAP measured between the various layers of clothing.
Tidsramme: 20 minutes
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
Tidsramme: 20 minutes
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.
Tidsramme: 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
Tidsramme: 24 hours
Difference in the mean of MAP measured between sleeves and control group in hypotensive patients
24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: JEREMY CHARLES, MD, University Hospital, Grenoble

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. januar 2027

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 38RC26.0150
  • IDRCB :2026-A00880-51 (Anden identifikator: CPP ILE DE FRANCE X (French Ethics Committees))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

At the time of publication

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blodtryk

Kliniske forsøg med Blood pressure measurement

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