Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
Primary Purpose
Hypoxia, Hypercapnia, Anaemia
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
conventional ABG analyser
Proxima 3®
Sponsored by
About this trial
This is an interventional other trial for Hypoxia focused on measuring arterial blood gas
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
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional ABG analyser
Proxima 3® arterial blood gas
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to obtain an arterial blood gas
Time for obtaining arterial blood gas: prelevation time to result time
Full Information
NCT ID
NCT02801162
First Posted
May 31, 2016
Last Updated
October 11, 2018
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02801162
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
To much effort needed, high costs for an academic study
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia, Anaemia
Keywords
arterial blood gas
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional ABG analyser
Arm Type
Active Comparator
Arm Title
Proxima 3® arterial blood gas
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
conventional ABG analyser
Intervention Description
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
Intervention Type
Device
Intervention Name(s)
Proxima 3®
Intervention Description
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
Primary Outcome Measure Information:
Title
Evaluation of accuracy and precision of the Proxima 3® for ABG
Description
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
Secondary Outcome Measure Information:
Title
Time to obtain an arterial blood gas
Description
Time for obtaining arterial blood gas: prelevation time to result time
Time Frame
From intubation until extubation, max 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Umbrain, MD PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, MD, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuella Martin, Apr. Biol.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christine Sneyers, Nurse
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriel Kotolácsi, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Matagne, Nurse
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams-Brabant
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
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