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

NCT ID: NCT02801162

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-30

Brief Summary

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.

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.

Conditions

Hypoxia; Hypercapnia; Anaemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Conventional ABG analyser

Group Type: ACTIVE_COMPARATOR

conventional ABG analyser

Intervention Type: DEVICE

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Proxima 3®

Intervention Type: DEVICE

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Proxima 3® arterial blood gas

Group Type: EXPERIMENTAL

conventional ABG analyser

Intervention Type: DEVICE

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Proxima 3®

Intervention Type: DEVICE

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Interventions

conventional ABG analyser

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Intervention Type: DEVICE

Proxima 3®

pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Umbrain, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Jan Poelaert, MD, PhD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Manuella Martin, Apr. Biol.

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Christine Sneyers, Nurse

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Gabriel Kotolácsi, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Pierre Matagne, Nurse

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

PROXIMA

Identifier Type: -

Identifier Source: org_study_id