Clinical trial NCT03852147: Individualized Hemodynamic Optimization by Indirect Measurement of the Respiratory Quotient in Major Surgery: Prospective Randomized Multicentre Open-Label Study (OPHIQUE) Individualized Optimization by Indirect Measurement of the Respiratory Quotient
Official title: Individualized Hemodynamic Optimization by Indirect Measurement of the Respiratory Quotient in Major Surgery: Prospective Randomized Multicentre Open-Label Study (OPHIQUE) Individualized Optimization by Indirect Measurement of the Respiratory Quotient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Complication
Respiratory Complication
Keywords: respiratory quotient
post operative complications
anaerobic metabolism
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: st isabelle health center, abbeville
name: Centre Hospitalier Universitaire de Caen
name: Centre Hospitalier VALENCIENNES
First posted: 2019-02-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Abdominal, orthopedic or vascular surgery with general anesthesia
* ASA score ≥ II
* Estimated duration of surgery\> 2 hours
* Consent signed.
* Affiliation to a social security scheme

Exclusion Criteria:

* Untreated or unbalanced severe hypertension under treatment.
* Preoperative renal failure dialyzed.
* Acute heart failure.
* Acute coronary insufficiency.
* Vascular surgery with kidney plasty.
* Cardiac surgery.
* Permanent laparoscopy.
* Preoperative shock state.
* Refusal of patient's participation
* Pregnant woman, parturient or breastfeeding.
* Patient under guardianship or trusteeship, under the protection of justice or private public law.
* Anesthesia with loco-regional anesthesia (spinal anesthesia and epidural).
* Acute respiratory distress syndrome (PaO2 / FiO2 ratio \<300).
* Chronic Respiratory Failure with Home Oxygen Therapy.
* Patient already included in another therapeutic trial with an experimental molecule.
* Emergency anesthesia

Primary outcomes:
measure: organ failure
timeFrame: 7 days postoperatively
measure: mortality rate at day 30
timeFrame: 30 days
Secondary outcomes:
measure: the length of stay in the hospital
timeFrame: 30 days
measure: the SOFA score at day1
timeFrame: 1 day
measure: the SOFA score at day2
timeFrame: 2 days
measure: the SOFA score at day7
timeFrame: 7 days
measure: total volume of fluid intraoperatively
timeFrame: 30 days
measure: Plasma creatinine measured on day 0, day 1, day 2 and day 7 postoperatively
timeFrame: 7 days
measure: Plasma lactate measured on day 1, day 2 and day 7 postoperatively
timeFrame: 7 days
measure: C Reactive protein measured on day1, day2 and day7 postoperative
timeFrame: 7 days
measure: Troponin Tc measured on day1, day2 and day7 postoperatively
timeFrame: 7 days
measure: (NT pro) Brain Natriuretic Peptide ((NT pro) BNP) measured at day1, day2 and day7 postoperative
timeFrame: 7 days
measure: the incidence of each complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: BAR
Study officials:
affiliation: CHU Amiens
name: Stéphane Bar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.