- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Prudence MABIALA MAKELE, PhD
- Telefonnummer: 0033476766784
- E-Mail: pmabialamakele@chu-grenoble.fr
Studieren Sie die Kontaktsicherung
- Name: JEREMY CHARLES, MD
- Telefonnummer: 0033476766784
- E-Mail: PBordas@chu-grenoble.fr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Differences between MAP measured over clothing and the average MAP measured on the bare arm
Zeitfenster: 20 minutes
|
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
|
20 minutes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Differences between MAP measured between the various layers of clothing.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 24 hours
|
Difference in the mean of MAP measured between sleeves and control group in hypotensive patients
|
24 hours
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: JEREMY CHARLES, MD, University Hospital, Grenoble
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 38RC26.0150
- IDRCB :2026-A00880-51 (Andere Kennung: CPP ILE DE FRANCE X (French Ethics Committees))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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