- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01753895
Mercury Versus Automated Blood Pressure Monitoring
Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Despite the clear guidelines on manual blood pressure technique, there seems to be large inter-observer variations, both among nursing staff and physicians. These differences are further complicated by variables such as cuff selection and application, incorrect cuff positioning and rapid cuff deflation rate, inadequate rest period, and lack of repeated measurements. The blood pressure measurement obtained by an automated device is not as dependent on observer training and competency as the manual mercury device, yet its use requires careful patient evaluation for caffeine or nicotine use, cuff position, and proper wrist positioning, and instructing the individual not to move or talk if accurate blood pressures are to be obtained. If one performs the automated readings and manual blood pressure measurements under standardized conditions, the mean values will be quite similar; however, this possibility has not yet been fully tested.
Therefore, there is a need to assess systematically if there is in fact a difference in the two blood pressure monitoring approaches under controlled conditions. The goal of this study, then, is to examine our current practice of obtaining manual blood pressure measurement using a mercury sphygmomanometer compared to an automated wrist-mounted blood pressure device.
A possible implication of this study is if the blood pressure measurements using the automated blood pressure device are comparable to the measurements obtained using the mercury sphygmomanometer, than the mercury devices can be replaced by the more environmentally acceptable automated devices in our clinical research setting.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- The Rockefeller University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male or Female >18 and < 100 years of age
- With or without history of hypertension on or off antihypertensive medications
- Able to understand the information in the informed consent form and can provide written consent
- Upper arm and wrist access
Exclusion Criteria:
- Latex allergy
- Upper arm circumference > 52mm
- Wrist circumference < 5 inches and > 8 3/4 inches
- History of Mastectomy or Upper Extremity Peripheral Vascular Disease
- History of Carpal Tunnel Disease
- History of surgical repair of varicosities in the upper arm or wrist
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Assess difference in blood pressure readings in standard brachial vs. wrist-mounted radial blood pressure measurement
Délai: 1 outpatient visit and data will be analyzed at study completion
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This study will assess any differences in blood pressure readings noted between standard brachial blood pressure measurement and wrist-mounted radial blood pressure measurement
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1 outpatient visit and data will be analyzed at study completion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arlene Hurley, MA, ANP, CCRC, The Rockefeller University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- AHU-0759
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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