What is the level of agreement between the gold standard, which includes invasive DO2 and VO2 measurements (with pulmonary artery catheter and central venous line), when compared with DO2 and VO2 measurements derived by a minimal invasive approach (…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Invasive and minimal invasive measurements of DO2, VO2 and the oxygen
extraction ratio.
Secondary outcome
* Cardiac output
* Hemoglobin measurements in the laboratory and using a point of care device
* SpO2
* SaO2
* SvO2/ScvO2
* O2ER
* Lactate
Background summary
The balance between tissue oxygen delivery (DO2) and oxygen consumption (VO2)
is indicative for tissue metabolism and local oxygen requirements.
Unfortunately, DO2 and VO2 measurements are limited to settings where patients
receive intensive invasive hemodynamic monitoring, such as cardiosurgical
procedures or the intensive care unit. In this study, we aim to validate a
minimal invasive approach to assess the DO2 and VO2 using Nexfin-based cardiac
output measurements, point-of-care hemoglobin measurements and SaO2
measurements by pulse oximetry, and inspiratory and expiratory O2 levels for
the calculation of VO2. The obtained values will be compared with DO2 and VO2
levels derived from the gold standard approach that includes an invasive
pulmonary artery catheter and central venous line.
Study objective
What is the level of agreement between the gold standard, which includes
invasive DO2 and VO2 measurements (with pulmonary artery catheter and central
venous line), when compared with DO2 and VO2 measurements derived by a minimal
invasive approach (using pulse oximetry, Nexfin, cardiac output, inspiratory
and expiratory O2 levels), in patients undergoing cardiac surgery?
Study design
* Single center, observational study in patients who are scheduled for elective
cardiac surgery with a pulmonary artery catheter and central venous line.
* Parallel measurements of invasive and non-invasive parameters that are
required to calculate DO2 and VO2.
* Study measurements take place during anesthesia and surgery
* Study procedures include pulse oxymetry, blood sample measurements and
cardiac output determination.
Study burden and risks
There are no benefits nor risks associated with the present study proposal. A
total of 20 ml of extra blood will be drawn from an existing intravascular
catheter while the patient is under anesthesia. The use of a central venous
line and pulmonary artery catheter are part of routine clinical practice in
patients undergoing cardiac surgery with cardiopulmonary bypass.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Elective cardiac surgery
* Older than 18 years
* Presence of a pulmonary artery catheter and central venous line
Exclusion criteria
* Re-operation
* Aortic valve surgery in cas of severe aortic stenosis
* Bentall surgery
* Arrhythmias (may dampen the signal of pulse oximetry)
* Anemia (Hemoglobin levels of 5.5 mmol/L or lower; decreases oxygen delivery)
* Severe COPD (adaptation of peripheral microvasculature to chronic hypoxia; Gold 3/4)
* Intra-cardiac shunt
* ASA score of 4 and higher and NYHA score exceeding 4
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL53854.029.15 |