Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard

Evaluation of Accuracy and Precision of the Proxima 3® (Sphere Medical) Arterial Blood Gas Analysis System in Comparison With the Reference Standard Hospital ABG in a Rapidly Changing Clinical Context

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.

Study Overview

• Status: Terminated
• Conditions: Hypoxia; Hypercapnia; Anaemia
• Intervention / Treatment: Device: conventional ABG analyser; Device: Proxima 3®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Jette, Vlaams-Brabant, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female patients ≥18 years old
• Patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study
• Patients who give informed consent (or their personal/nominated consultee) to participate in the study
• Patients who are likely to have an arterial line for at least 6 hours.

Exclusion Criteria:

• Patients contraindicated for an arterial line
• Refusal of consent by a patient
• Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
• The patient is considered to be unsuitable for the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional ABG analyser	Device: conventional ABG analyser; pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %; Device: Proxima 3®; pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
Experimental: Proxima 3® arterial blood gas	Device: conventional ABG analyser; pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %; Device: Proxima 3®; pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From intubation until extubation, max 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to obtain an arterial blood gas	Time for obtaining arterial blood gas: prelevation time to result time	From intubation until extubation, max 1 day

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Vincent Umbrain, MD PhD, Universitair Ziekenhuis Brussel; Study Director: Jan Poelaert, MD, PhD, Universitair Ziekenhuis Brussel; Study Chair: Manuella Martin, Apr. Biol., Universitair Ziekenhuis Brussel; Principal Investigator: Christine Sneyers, Nurse, Universitair Ziekenhuis Brussel; Principal Investigator: Gabriel Kotolácsi, MD, Universitair Ziekenhuis Brussel; Principal Investigator: Pierre Matagne, Nurse, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimated): June 15, 2016

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: arterial blood gas
• Additional Relevant MeSH Terms: Hematologic Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Hypoxia; Anemia; Hypercapnia
• Other Study ID Numbers: PROXIMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES