Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03852147 |
| Other study ID # |
PI2018_843_0014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 26, 2018 |
| Est. completion date |
January 26, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Centre Hospitalier Universitaire, Amiens |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily
monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to
VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of
the patient, and an indirect reflection of tissue perfusion. We hypothesize that a
hemodynamic optimization in major surgery individualized by non-invasive continuous
measurement of the RQ would optimize TaO2 more specifically by informing us about the
installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are
randomized in 2 groups : Control group: hemodynamic management of patients is done according
to usual practices by maintenance of blood pressure by norepinephrine as well as optimization
of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental
group: perioperative hemodynamic management is based on an algorithm that includes RQ
measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion
and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the
surgery.
Description:
• Background : The measurement of the inspired / expired fractions in O2 and CO2 is part of
the daily monitoring of the intubated-ventilated patient in the operating theater. Changes in
EtCO2 may reflect changes in metabolic CO2 production (VCO2), and oxygen extraction from the
body (SvO2). The inspired / exhaled oxygen difference is an indirect reflection of the oxygen
consumption (VO2). The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive
indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue
perfusion.
Some studies, including a recent one carried out by our center, showed that the RQ was linked
to the appearance of anaerobic metabolism and to the postoperative evolution of the patient.
The RQ was correlated with arterial lactate levels and predicted the occurrence of
postoperative complications. Thus, the RQ can be a reliable, continuous, non-invasive marker
of anaerobic metabolism in the operating room and therefore of the adequacy of arterial
oxygen Transport (TaO2) with respect to the VO2 of the patient
- Purpose : Th investigators hypothesize that a hemodynamic optimization in major surgery
individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more
specifically by informing us about the installation of a VO2 dependence, and therefore
of an anaerobic metabolism.
- Brief summary:
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily
monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to
VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of
the patient, and an indirect reflection of tissue perfusion. We hypothesize that a
hemodynamic optimization in major surgery individualized by non-invasive continuous
measurement of the RQ would optimize TaO2 more specifically by informing us about the
installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are
randomized in 2 groups : Control group: hemodynamic management of patients is done according
to usual practices by maintenance of blood pressure by norepinephrine as well as optimization
of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental
group: perioperative hemodynamic management is based on an algorithm that includes RQ
measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion
and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the
surgery.
Number of groups and description of groups :
2 groups Control group: hemodynamic management of patients is done according to usual
practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by
vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that
includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC
transfusion and dobutamine.
• Interventions : Control group: hemodynamic management of patients is done according to
usual practices by maintenance of blood pressure by norepinephrine as well as optimization of
SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that
includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC
transfusion and dobutamine.
The primary outcome is defined by at least one organ failure within 7 days postoperatively.
The duration of participation of each patient is 30 days and total research term is 49 months
- Number of subjects : 350
- Statistical analysis : The null hypothesis will be rejected in favor of the alternative
hypothesis (there is a difference) using a test of χ2 or a Fisher test according to the
frequency of the complications with a risk of the first bilateral species of 5%.
- Key-words : respiratory quotient, post opérative complications, anaerobic metabolism.
