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

NCT03852147 | Completed DMC

• 1 other identifier: PI2018_843_0014
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Op Complication; Respiratory Complication

Keywords

respiratory quotient; post operative complications; anaerobic metabolism

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• the length of stay in the hospital

  30 days

• the SOFA score at day1

  1 day

• the SOFA score at day2

  2 days

• the SOFA score at day7

  7 days

• total volume of fluid intraoperatively

  30 days

Study Arms (2)

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.

Procedure: : hemodynamic management

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.

Procedure: : hemodynamic management

Interventions

: 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.

Control group; Experimental group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• st isabelle health center, abbeville: collaborator
• Centre Hospitalier Universitaire de Caen: collaborator
• Centre Hospitalier VALENCIENNES: collaborator

Study Sites (1)

BAR

Amiens, 80054, France

Location

Related Publications (3)

• 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.

  PMID: 33228773 RESULT

• 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.

  PMID: 37992534 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.

  PMID: 36958473 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Bar, Dr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: December 26, 2018
• Primary Completion: December 26, 2022
• Study Completion: January 26, 2023
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)