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| Name | Class |
|---|---|
| st isabelle health center, abbeville | UNKNOWN |
| Centre Hospitalier Universitaire de Caen | OTHER |
| Centre Hospitalier VALENCIENNES | OTHER |
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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.
• 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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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 | Experimental | perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| : hemodynamic management | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| organ failure | at least one organ failure within 7 days postoperatively. • Organ failure is defined according to the recommendations of the European Anesthesia Society (ESA) and the European Resuscitation Society (ESICM). | 7 days postoperatively |
| mortality rate at day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| the length of stay in the hospital | 30 days | |
| the SOFA score at day1 | The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Bar, Dr | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BAR | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228773 | Result | Bar S, Boivin P, El Amine Y, Descamps R, Moussa M, Abou Arab O, Fischer MO, Dupont H, Lorne E, Guinot PG. Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study). Trials. 2020 Nov 23;21(1):958. doi: 10.1186/s13063-020-04879-x. | |
| 37992534 |
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|
| 1 day |
| the SOFA score at day2 | The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points. | 2 days |
| the SOFA score at day7 | The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points. | 7 days |
| total volume of fluid intraoperatively | 30 days |
| Plasma creatinine measured on day 0, day 1, day 2 and day 7 postoperatively | 7 days |
| Plasma lactate measured on day 1, day 2 and day 7 postoperatively | 7 days |
| C Reactive protein measured on day1, day2 and day7 postoperative | 7 days |
| Troponin Tc measured on day1, day2 and day7 postoperatively | 7 days |
| (NT pro) Brain Natriuretic Peptide ((NT pro) BNP) measured at day1, day2 and day7 postoperative | 7 days |
| the incidence of each complication | 30 days |
| Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPHIQUE study group. Determinants of postoperative complications in high-risk noncardiac surgery patients optimized with hemodynamic treatment strategies: A post-hoc analysis of a randomized multicenter clinical trial. J Clin Anesth. 2024 May;93:111325. doi: 10.1016/j.jclinane.2023.111325. Epub 2023 Nov 22. |
| 36958473 | Result | Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPtimization Hemodynamic Individualized using the respiratiory QUotiEnt (OPHIQUE) Trial Group. Respiratory Exchange Ratio guided management in high-risk noncardiac surgery: The OPHIQUE multicentre randomised controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101221. doi: 10.1016/j.accpm.2023.101221. Epub 2023 Mar 21. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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