An interventional study of conventional ABG analyser and Proxima 3® in Hypoxia, Hypercapnia and Anaemia, sponsored by Universitair Ziekenhuis Brussel. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Other
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.
In this study the investigator will test the applicability of the Proxima 3® ABG system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. The investigator will compare the ABG values obtained with the traditional ABG measurement system of the hospital.
The availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. As well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs.
The conventional laboratory ABG method uses sensor technology for pH, pCO2, pO2, sodium, potassium, calcium, glucose and lactate levels. It measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. The blood gas laboratory uses ABL90 Flex (Radiometer®). The optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Device: conventional ABG analyser · Device: Proxima 3®
Device: conventional ABG analyser · Device: Proxima 3®
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
Evaluation of accuracy and precision of the Proxima 3® for ABG
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points
Time frame: From intubation until extubation, max 1 day
Time to obtain an arterial blood gas
Time for obtaining arterial blood gas: prelevation time to result time
Time frame: From intubation until extubation, max 1 day
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Feb 2017, 5 months.
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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