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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801162
Recruitment Status : Terminated (To much effort needed, high costs for an academic study)
First Posted : June 15, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Hypoxia Hypercapnia Anaemia Device: conventional ABG analyser Device: Proxima 3® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017

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 %




Primary Outcome Measures :
  1. Evaluation of accuracy and precision of the Proxima 3® for ABG [ Time Frame: From intubation until extubation, max 1 day ]
    Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points


Secondary Outcome Measures :
  1. Time to obtain an arterial blood gas [ Time Frame: From intubation until extubation, max 1 day ]
    Time for obtaining arterial blood gas: prelevation time to result time



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801162


Locations
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Belgium
Universitair Ziekenhuis Brussel
Jette, Vlaams-Brabant, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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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
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Responsible Party: Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02801162    
Other Study ID Numbers: PROXIMA
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
arterial blood gas
Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms