Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery (The BAR Study)

September 17, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery as a Predictor of Anaerobic Metabolism (The BAR Study) Indirect Respiratory Quotient as a Predictor of Anaerobic Metabolism

Demonstrate the ability of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of anaerobic metabolism in patients operated of major non-cardiac surgical operation in the operating room

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Indirect respiratory quotient (RQ) measurement involves indirect calorimetry, which measures O2 and CO2 inspired and expired fractions. This measurement is usually used to estimate energy expenditure and which energetic substrate is preferentially used in resuscitation patients. Litterature demonstrated in a mouse model that the formation of hemorrhagic shock was associated with a change in RQ due to VCO2 and VO2 imbalance. RQ was able to distinguish anaerobic metabolism and corrected itself with correction of shock. Recently in Litterature showed a link between lactate production, cardiac output and the evolution of the RQ measured by indirect calorimetry in a resuscitation patient. Also, these authors raise the question of a possible use of the RQ in intensive care as an early non-invasive marker of anaerobic metabolism that can replace the invasive ones usually used (arterial lactate, venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference, ScVO2). However, the measurement of inspired and expired fractions in O2 and CO2 is part of the systematic monitoring of the intubated-ventilated patient in the operating room. The measurement of the VO2, VCO2 and the RQ could therefore be done from these fractions inspired and expired in O2 and CO2 by the following equation:

RQ = (FeCO2-FiCO2) / (FiO2-FeO2) The main objective of our work is to demonstrate the ability of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of anaerobic metabolism in patients operated of major non-cardiac surgical operation in the operating room. Secondly, the objective is to evaluate the association between the variations of the RQ, EtCO2, Dc, ScVO2, venoarterial PCO2 gradient, venoarterial PCO2 gradient/arteriovenous O2 content difference and lactate levels at different times during the surgical procedure and depending on the occurrence of postoperative complications.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • CHU Amiens-Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the operating room of Amiens University Hospital supported for major non-cardiac surgery (abdominal, orthopedic, vascular) for which the practitioner had decided in accordance with the care protocols of the department to carry out an hemodynamic optimization

Description

Inclusion Criteria:

  • Adult patients admitted to the operating room of Amiens University Hospital supported for major non-cardiac surgery (abdominal, orthopedic, vascular) for which the practitioner had decided in accordance with the care protocols of the department to carry out an hemodynamic optimization,
  • Patients monitored by a central venous catheter and an invasive measurement of blood pressure,
  • Ventilated patients in controlled mode,
  • Major patients.

Exclusion Criteria:

  • Cardiac surgery with the need of extracorporeal circulation
  • Thoracic surgery with the need of unipulmonary ventilation
  • Permanent laparoscopic surgery and up to 30 minutes after exsufflation of CO2
  • Acute or chronic respiratory insufficiency documented
  • Interstitial lung disease with diffusion disorders
  • Preoperative oxygen therapy
  • Acute Respiratory Distress Syndrome with FiO2> 60%.
  • Refusal of patient participation.
  • Pregnant woman.
  • Patient under guardianship or curatorship or deprived of public right.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Quotient (RQ)
Time Frame: 1 Month
indirectly measured from the anesthetic respirator, and its predictive ability to develop anaerobic metabolism.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stéphane BAR, Dr, CHU Amiens-Picardie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2017

Primary Completion (ACTUAL)

August 30, 2018

Study Completion (ACTUAL)

August 30, 2018

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PI2017_843_0006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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