Clinical trial NCT04144296: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Keywords: Arterial blood gas analysis
Capillary blood gas analysis
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: OBI Medical
First posted: 2019-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
timeFrame: 10 minutes after the first blood sample is taken
Secondary outcomes:
measure: Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
timeFrame: 10 minutes after the first blood sample is taken
measure: Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples
timeFrame: 10 minutes after the first blood sample is taken
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Clinic for pneumology and internal intensive care
Study officials:
References: