- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07687771
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.
Studieoversigt
Status
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
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Prudence MABIALA MAKELE, PhD
- Telefonnummer: 0033476766784
- E-mail: pmabialamakele@chu-grenoble.fr
Undersøgelse Kontakt Backup
- Navn: JEREMY CHARLES, MD
- Telefonnummer: 0033476766784
- E-mail: PBordas@chu-grenoble.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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
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:
|
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
Sponsor
Efterforskere
- Ledende efterforsker: JEREMY CHARLES, MD, University Hospital, Grenoble
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
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)?
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
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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