Clinical trial NCT02801162: Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoxia
Hypercapnia
Anaemia
Keywords: arterial blood gas
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Evaluation of accuracy and precision of the Proxima 3® for ABG
timeFrame: From intubation until extubation, max 1 day
Secondary outcomes:
measure: Time to obtain an arterial blood gas
timeFrame: From intubation until extubation, max 1 day
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams-Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Vincent Umbrain, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Manuella Martin, Apr. Biol.
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Christine Sneyers, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Gabriel Kotolácsi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Pierre Matagne, Nurse
role: PRINCIPAL_INVESTIGATOR
References: