NCT02801162

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 18, 2025

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

May 31, 2016

Last Update Submit

November 14, 2025

Conditions

HypoxiaHypercapniaAnaemia

Keywords

arterial blood gas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time to obtain an arterial blood gas

    From intubation until extubation, max 1 day

Study Arms (2)

Conventional ABG analyser

ACTIVE COMPARATOR
Device: conventional ABG analyserDevice: Proxima 3®

Proxima 3® arterial blood gas

EXPERIMENTAL
Device: conventional ABG analyserDevice: Proxima 3®

Interventions

conventional ABG analyserDEVICE

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

Conventional ABG analyserProxima 3® arterial blood gas
Proxima 3®DEVICE

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

Conventional ABG analyserProxima 3® arterial blood gas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients ≥18 years old
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

HypoxiaHypercapniaAnemia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Vincent Umbrain, MD PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Jan Poelaert, MD, PhD

    Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

  • Manuella Martin, Apr. Biol.

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

  • Christine Sneyers, Nurse

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Gabriel Kotolácsi, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Pierre Matagne, Nurse

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 15, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

November 18, 2025

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Locations

BE(1)