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

NCT04144296 | Unknown

• 1 other identifier: 18-125
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Arterial blood gas analysis; Capillary blood gas analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes after the first blood sample is taken

Secondary Outcomes (2)

• Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples

  10 minutes after the first blood sample is taken

• Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples

  10 minutes after the first blood sample is taken

Study Arms (1)

Study Arm

OTHER

All patient will be included in this arm

Diagnostic Test: Study procedure

Interventions

Study procedure DIAGNOSTIC_TEST

* 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

Study Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• OBI Medical: collaborator

Study Sites (1)

Clinic for pneumology and internal intensive care

Aachen, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Tobias Müller, PD Dr. med.

CONTACT

+492418036470; tobmueller@ukaachen.de

Ayham Daher, Dr. med.

CONTACT

adaher@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 30, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

DE (1)