Analysis of the Arterial Pressure Wave Form Through the Proxima Device
An Open, Non-randomised, Study to Provide Data on the Arterial Pressure Wave Form Obtained Through the Proxima 3 in Patients Who Require the Insertion of an Arterial Line
The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be:
• To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial line compared to various arterial lines fitted with the Proxima 3.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The purpose of this study is to examine the transmission of the arterial pressure wave form through Proxima 3 disposable attached to a configurable parts of the patient's arterial line. The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to comply to BS EN 60601-1 2nd edition "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". Additional internal tests have also been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).
This study part of the on-going development of the Proxima system which monitors metabolic parameters in critically ill patients using a disposable sensor array. This study builds upon the four clinical trials carried out in the past two years by Sphere Medical in partnership with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).
This study forms part of the development process for the Proxima family of devices.
The Proxima 3:
- Is a disposable multi-parameter microanalyser
- Is connected into the patient's arterial line.
- Will measure all or some of blood gases, haematocrit and electrolytes and is connected to a small bedside monitor, which displays the results.
- Microanalyser can perform an unlimited number of analyses over a period of up to seventy two hours.
- Will be used as part of a closed system, reducing infection risk and preventing blood loss.
Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's bedside. This will support the ability to respond rapidly to changing conditions in their critically ill patients. The measurements made by the Proxima 3 system have the potential to inform clinical decision support systems and to change, at a fundamental level, the ability of clinicians to improve patient care.
In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3 monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will occur in this study.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Edgbaston
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City and Borough of Birmingham, Edgbaston, Royaume-Uni, B15 2WB
- Queen Elizabeth Hospital
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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 and female patients over the age of 18
- Patients will give full informed consent to participate in the study before inclusion.
- All patients who have an arterial line inserted as standard care will be considered for inclusion.
Exclusion Criteria:
- Refusal of consent to participate
- The patient is considered by the investigator to be unsuitable for the study
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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To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form
Délai: 10 minutes maximum
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The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.
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10 minutes maximum
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Thomas Clutton-Brock, MB ChB FRCP, Queen Elizabeth Hopsital, Birmingham, UK
Publications et liens utiles
Liens utiles
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
- PROX005
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