SurgeryNCT03471962
Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery (The BAR Study)
An observational study of Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- surgery
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2017to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Acute Respiratory Distress Syndrome with FiO2> 60%.
- Refusal of patient participation.
- Pregnant woman.
- Patient under guardianship or curatorship or deprived of public right.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Surgery
- Being tested
- surgery
- Keywords
- respiratory quotient (RQ), anaerobic metabolism, major surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
Indirect measurement of RQ was performed by anesthesia ventilator and compared to marker of anaerobic metabolism (arterial lactate, venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference, ScVO2) at different time of the srugery (every hours). In post-operative time, complications and hospital's length of stay were recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Quotient (RQ)
indirectly measured from the anesthetic respirator, and its predictive ability to develop anaerobic metabolism.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start4 May 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane BAR, Dr, Principal investigator, CHU AMIENS-PICARDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471962
- Sponsor's protocol ID
- PI2017_843_0006
- Status last verified
- Aug 2018
- First submitted
- 14 Mar 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bar S, Grenez C, Nguyen M, de Broca B, Bernard E, Abou-Arab O, Bouhemad B, Lorne E, Guinot PG. Predicting postoperative complications with the respiratory exchange ratio after high-risk noncardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Nov;37(11):1050-1057. doi: 10.1097/EJA.0000000000001111.
PubMed 31688330
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03471962
- Acronym / sponsor ID
- PI2017_843_0006
- Conditions
- Surgery
- Keywords
- respiratory quotient (RQ), anaerobic metabolism, major surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryIndirect measurement of RQ was performed by anesthesia ventilator and compared to marker of anaerobic metabolism (arterial lactate, venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference, ScVO2) at different time of the srugery (every hours). In post-operative time, complications and hospital's length of stay were recorded. | Other | – |
Primary outcome
Respiratory Quotient (RQ)
Time frame: 1 Month
indirectly measured from the anesthetic respirator, and its predictive ability to develop anaerobic metabolism.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 31688330Bar S, Grenez C, Nguyen M, de Broca B, Bernard E, Abou-Arab O, Bouhemad B, Lorne E, Guinot PG. Predicting postoperative complications with the respiratory exchange ratio after high-risk noncardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Nov;37(11):1050-1057. doi: 10.1097/EJA.0000000000001111.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane BAR, Dr principal investigator
CHU AMIENS-PICARDIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Quotient (RQ) (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.