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Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients

Primary Purpose

Lung Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Study procedure
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring Arterial blood gas analysis, Capillary blood gas analysis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission to the intensive / intermediate care or weaning unit at the department of pneumology and intensive care medicine of the university hospital RWTH Aachen
  • Arterial line inserted to monitor the patient's blood pressure or respiratory status
  • Male or female aged ≥ 18 years
  • Written informed consent prior to study participation
  • The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

  • Hemodynamic instability
  • Impaired perfusion of peripheral limbs e.g. due to severe heart failure
  • Pregnant and lactating females. Pregnancy will be ruled out in females of childbearing age by pregnancy test.
  • Patient has been committed to an institution by legal or regulatory order
  • The subject is mentally or legally incapacitated

Sites / Locations

  • Clinic for pneumology and internal intensive careRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Arm

Arm Description

All patient will be included in this arm

Outcomes

Primary Outcome Measures

Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pO2 Levels will be measured using a blood gas analyser. Afterwards pO2 levels in the capillary sample will be compensated by VTAC software and compensated pO2 levels will be compared to arterial PO2 levels using the Bland-Altman method.

Secondary Outcome Measures

Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pCO2 Levels will be measured using a blood gas analyser. Afterwards pCO2 levels in the capillary sample will be compensated by VTAC software and compensated pCO2 levels will be compared to arterial PCO2 levels using the Bland-Altman method.
Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pH will be measured using a blood gas analyser. Afterwards pH in the capillary sample will be compensated by VTAC software and compensated pH will be compared to arterial pH levels using the Bland-Altman method.

Full Information

First Posted
October 21, 2019
Last Updated
September 20, 2021
Sponsor
RWTH Aachen University
Collaborators
OBI Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04144296
Brief Title
Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients
Official Title
Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
Collaborators
OBI Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to compare capillary blood gas analysis compensated by v-TAC software (aCBGE, aCBGF) to arterial blood gas analysis (ABG) in terms of pH, pCO2 and pO2 and the clinical usefulness of this method compared to the gold standard of ABG.
Detailed Description
In clinical practice blood gas analysis is an essential tool for monitoring respiratory status. The gold-standard method is arterial blood gas analysis (ABG) of blood from the patient's radial or femoral artery. An alternative to arterial sampling commonly used is arterialized capillary blood gas analysis from the earlobe (CBGE). Though CBGE is less invasive and can be performed by non-medical staff, it is less useful in the acute setting because an adequate vasodilatation is needed which typically lasts for at least 10 minutes and the quality of results tends to be operator dependable. Different trials have evaluated the agreement between ABG and CBGE. Whereas a close agreement between ABG and CBGE has been found for evaluating pH and the partial pressure of carbon dioxide (PCO2), several trials showed considerable variations for the partial pressure of oxygen (PO2) and that CBGE tends to underestimate PO2. Similar findings apply for capillary blood gas analysis from the fingertip (CBGF) which is even less accurate compared to CBGE in estimating PO2. Recently a method has been developed to calculate ABG values mathematically from peripheral venous blood, supplemented with oxygen saturation (SpO2) measurement by pulse oximetry, by use of venous-to-arterial conversion (v-TAC) software (OBI Medical, Denmark). The principle of the method is a mathematical transformation of venous blood gas analysis (VBG) values to arterialised values (aVBG) by simulating the transport of blood back through the tissue (6). This approach leads to a clinically acceptable agreement between ABG and aVBG for pH and PCO2. For PO2 the limits of agreement of aVBG are similar to those of PO2 from CBGE for values below 75 mmHg and with mean bias close to zero. However, it has not been evaluated previously whether v-TAC software can be used to calculate ABG values from CBGE (aCBGE) or CBGF (aCBGF). As CBGE and CBGF values are much closer to ABG values, compared to VBG values, the agreement between aCBGE/aCBGF and ABG in terms of pH, PCO2 and pO2 might be better compared to CBG without mathematical arterialisation by v-TAC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Arterial blood gas analysis, Capillary blood gas analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Other
Arm Description
All patient will be included in this arm
Intervention Type
Diagnostic Test
Intervention Name(s)
Study procedure
Intervention Description
Measurement of the flow rate of supplemental oxygen Measurement of the peripheral arterial saturation (SpO2) by pulse oximetry Taking of an ABG sample (ABG1) from the arterial line Taking of capillary blood gas analysis from the earlobe and from the finger tip Taking of an a second ABG (ABG2) from the arterial line
Primary Outcome Measure Information:
Title
Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Description
Capillary and arterial pO2 Levels will be measured using a blood gas analyser. Afterwards pO2 levels in the capillary sample will be compensated by VTAC software and compensated pO2 levels will be compared to arterial PO2 levels using the Bland-Altman method.
Time Frame
10 minutes after the first blood sample is taken
Secondary Outcome Measure Information:
Title
Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Description
Capillary and arterial pCO2 Levels will be measured using a blood gas analyser. Afterwards pCO2 levels in the capillary sample will be compensated by VTAC software and compensated pCO2 levels will be compared to arterial PCO2 levels using the Bland-Altman method.
Time Frame
10 minutes after the first blood sample is taken
Title
Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples
Description
Capillary and arterial pH will be measured using a blood gas analyser. Afterwards pH in the capillary sample will be compensated by VTAC software and compensated pH will be compared to arterial pH levels using the Bland-Altman method.
Time Frame
10 minutes after the first blood sample is taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to the intensive / intermediate care or weaning unit at the department of pneumology and intensive care medicine of the university hospital RWTH Aachen Arterial line inserted to monitor the patient's blood pressure or respiratory status Male or female aged ≥ 18 years Written informed consent prior to study participation The subject is willing and able to follow the procedures outlined in the protocol Exclusion Criteria: Hemodynamic instability Impaired perfusion of peripheral limbs e.g. due to severe heart failure Pregnant and lactating females. Pregnancy will be ruled out in females of childbearing age by pregnancy test. Patient has been committed to an institution by legal or regulatory order The subject is mentally or legally incapacitated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Müller, PD Dr. med.
Phone
+492418036470
Email
tobmueller@ukaachen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ayham Daher, Dr. med.
Email
adaher@ukaachen.de
Facility Information:
Facility Name
Clinic for pneumology and internal intensive care
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Dreher, Univ.-Prof. Dr. med.
Email
mdreher@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Tobias Müller, PD Dr. med.

12. IPD Sharing Statement

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Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients

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