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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Edgbaston
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City and Borough of Birmingham, Edgbaston, Storbritannien, B15 2WB
- Queen Elizabeth Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Thomas Clutton-Brock, MB ChB FRCP, Queen Elizabeth Hopsital, Birmingham, UK
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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