All Conditions Requiring Non-cardiac SurgeryAoA QUALITYNCT06111248
Impact of Training on the Use of Software and Digital Monitoring Tools During General Anesthesia for Intermediate/Major-risk Surgery on Morbidity and Mortality at 28 Days
A study testing Training in people with All Conditions Requiring Non-cardiac Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Tools such as surgical plethysmographic index, state entropy, train-of-four monitors exist to optimize the conduct of general anesthesia in intermediate and major risk surgery as defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- All Conditions Requiring Non-cardiac Surgery
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,028 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 6 Feb 2025
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an ASA score 2-4.
- Patients due to be operated on under general anesthesia for any intermediate- or major-risk non-cardiac procedure lasting > 60 min.
- Patients affiliated to, or benefiting from, a health insurance plan.
Who cannot join
- Patients who have indicated their refusal to participate in the study.
- Patients scheduled for minor surgery.
- Patients with an ASA score 1 or 5.
- Patients due for outpatient surgery.
- Patients due for surgery under local or locoregional anesthesia.
- Impossibility of 28-day follow-up.
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- Patients participating in interventional research involving human subjects.
- Patients in an exclusion period determined by another study.
- Patients under court protection, guardianship or curatorship.
- Patients for whom it is impossible to provide clear information.
- Pregnant, parturient or breast-feeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Training Healthcare Teams (Quality Improvement Project) in the Combined Use of AoA Carestation Software and Digital Intraoperative Monitoring Tools (State Entropy, Surgical Pleth Index and Train-of-Four) During General Anesthesia for Intermediate- or Major-risk Surgery on Patient Morbidity and Mortality at 28 Days
Tools such as surgical plethysmographic index, state entropy, train-of-four monitors exist to optimize the conduct of general anesthesia in intermediate and major risk surgery as defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Although these monitors are available on anesthesia machines they are still under-used by teams due to lack of training, practice and a real understanding of their usefulness (operation, expected benefits). When used in conjunction with General Electric's AoA Carestation Insight software, these tools could have a real impact on morbidity and mortality at 28 days post-op. The aim of this prospective monocentric interventional "before/after" study is to assess the impact of training and encouraging teams to use these tools.
Read the detailed description
Recently, complex monitoring tools (nociception by surgical plethysmographic index monitoring, curare by train-of four monitoring, depth of anesthesia by state entropy monitoring) have been developed to optimize the conduct of general anesthesia in intermediate and major risk surgery (surgery defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery). In practice, these monitors optimize nociception and the depth of anesthesia, "neither too strong nor too light". These monitors are currently available on our anesthesia machines and can be used routinely. However, these monitors are under-used by teams due to lack of training, practice and real understanding of their usefulness (operation, expected benefits).
Excess nociception and depth of anesthesia are correlated with more postoperative complications, but no studies have ever shown that the combined use of these monitors (surgical plethysmographic index, state entropy, train-of-four) could significantly reduce postoperative morbidity and mortality in patients by optimizing the management of general anesthesia. Software (AoA Carestation insight, General Electric) connected to these monitors can :
- automatically query the use of intraoperative monitors;
- perform usage audits to monitor teams' adherence to their practices;
- coach teams by encouraging them to perform anesthesia while maintaining surgical plethysmographic index (SPI), state entropy (SE) and train-of-four (TOF) values within the thresholds considered in the literature as being optimal for anesthesia (formalized expert recommendations from the SFAR (Société Francaise d'Anesthésie et de Réanimation).
In a prospective monocentric interventional "before/after" study, the aim is to assess the impact of training and encouraging teams to use the AoA Carestation Insight software in conjunction with SPI, SE and TOF monitoring, on morbidity and mortality at 28 days post-op.
The hypothesis is that training and encouraging teams ("quality improvement project") to use these intraoperative monitoring tools (SPI, TOF, SE) during general anesthesia for intermediate- or major-risk surgery could significantly reduce 28-day morbidity and mortality (composite criterion).
- Being tested
- Training
- Keywords
- Anesthesia, Monitoring, Cardiovascular assessment, Anesthesiology Devices, Diagnostic and Monitoring Devices
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Staff training on the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 638 patients receiving the usual, standard management for anesthesia when undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk. |
| Experimental group | Experimental | 638 patients undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk who have been managed by staff trained in the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software. Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of death after surgery in the control group
YES/NO
Measured: Day 28
Occurrence of death after surgery in the experimental group
YES/NO
Measured: Day 28
Occurence of acute myocardial infarction after surgery in the control group
YES/NO
Measured: Day 28
Occurence of acute myocardial infarction after surgery in the experimental group
YES/NO
Measured: Day 28
Occurence of arterial or venous thrombosis after surgery in the control group
YES/NO
Measured: Day 28
Occurence of arterial or venous thrombosis after surgery in the experimental group
YES/NO
Measured: Day 28
Occurence of a stroke after surgery in the control group
YES/NO
Measured: Day 28
Occurence of a stroke after surgery in the experimental group
YES/NO
Measured: Day 28
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the control group
YES/NO
Measured: Day 28
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the experimental group
YES/NO
Measured: Day 28
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the control group
YES/NO
Measured: Day 28
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the experimental group
YES/NO
Measured: Day 28
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the control group
YES/NO
Measured: Day 28
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the experimental group
YES/NO
Measured: Day 28
Postoperative episodes of sepsis and infections (according to the 2001 international definitions of sepsis) in the control group
YES/NO
Measured: Day 28
Post-operative respiratory complications: defined as the need for intubation and/or non-invasive ventilation in the event of respiratory failure in the control group
YES/NO
Measured: Day 28
Acute kidney injury in the control group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
YES/NO
Measured: Day 28
Acute kidney injury in the experimental group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
YES/NO
Measured: Day 28
Surgical complications in the control group: need for re-operation for any reason and radiological intervention for abscess drainage
YES/NO
Measured: Day 28
Surgical complications in the experimental group: need for re-operation for any reason and radiological intervention for abscess drainage
YES/NO
Measured: Day 28
Unplanned admission or readmission to the intensive care unit: control group
YES/NO
Measured: Day 28
Unplanned admission or readmission to the intensive care unit: experimental group
YES/NO
Measured: Day 28
Secondary outcomes (49)
Length of hospital stay : Control group
The length of stay in conventional hospitalization and in continuing care will be collected from the patient's record.
Measured: Day 28
Length of hospital stay : Experimental group
The length of stay in conventional hospitalization and in continuing care will be collected from the patient's record.
Measured: Day 28
Length of stay (hours) in the post-procedure care department : Control group
The length of stay in the post-procedure care department = discharge time - time of entry into the post-procedure care department will be recorded in hours.
Measured: Day 28
Length of stay (hours) in the post-procedure care department : Experimental group
The length of stay in the post-procedure care department = discharge time - time of entry into the post-procedure care department will be recorded in hours.
Measured: Day 28
Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Control group
The length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) measured during the intervention will be recorded on the intervention report.
Measured: Day 28
Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Experimental group
The length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) measured during the intervention will be recorded on the intervention report.
Measured: Day 28
Number of episodes of nausea/vomiting up to 12 hours after surgery: Control group
The cumulative number of episodes of nausea/vomiting up to 12 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 12 hours post-operative.
Measured: 12 hours post-surgery
Number of episodes of nausea/vomiting up to 24 hours after surgery: Control group
The cumulative number of episodes of nausea/vomiting up to 24 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 24 hours post-operative.
Measured: 24 hours post-surgery
Number of episodes of nausea/vomiting up to 48 hours after surgery: Control group
The cumulative number of episodes of nausea/vomiting up to 48 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 48 hours post-operative.
Measured: 48 hours post-surgery
Number of episodes of nausea/vomiting up to 12 hours after surgery: Experimental group
The cumulative number of episodes of nausea/vomiting up to 12 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 12 hours post-operative.
Measured: 12 hours post-surgery
Number of episodes of nausea/vomiting up to 24 hours after surgery: Experimental group
The cumulative number of episodes of nausea/vomiting up to 24 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 24 hours post-operative.
Measured: 24 hours post-surgery
Number of episodes of nausea/vomiting up to 48 hours after surgery: Experimental group
The cumulative number of episodes of nausea/vomiting up to 48 hours after surgery will be recorded based on the need to resort to an intravenous or oral anti-emetic up to 48 hours post-operative.
Measured: 48 hours post-surgery
Post-surgical pain at 6 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 6 hours post-surgery
Post-surgical pain at 6 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 6 hours post-surgery
Post-surgical pain at 12 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 12 hours post-surgery
Post-surgical pain at 12 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 12 hours post-surgery
Post-surgical pain at 18 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 18 hours post-surgery
Post-surgical pain at 18 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 18 hours post-surgery
Post-surgical pain at 24 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 24 hours post-surgery
Post-surgical pain at 24 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 24 hours post-surgery
Post-surgical pain at 30 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 30 hours post-surgery
Post-surgical pain at 30 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 30 hours post-surgery
Post-surgical pain at 36 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 36 hours post-surgery
Post-surgical pain at 36 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 36 hours post-surgery
Post-surgical pain at 42 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 42 hours post-surgery
Post-surgical pain at 42 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 42 hours post-surgery
Post-surgical pain at 48 hours as measured by the Control group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 48 hours post-surgery
Post-surgical pain at 48 hours as measured by the Experimental group
Pain intensity at rest and on mobilization will be measured on a visual analog scale (in which 0 = no pain and 10 = highest imaginable pain) every 6 hours, for up to 48 hours after surgery.
Measured: At 48 hours post-surgery
Confusion : Control group
The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded.
Measured: Postoperative Day 1
Confusion : Control group
The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded.
Measured: Postoperative Day 2
Confusion : Experimental group
The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded.
Measured: Postoperative Day 1
Confusion : Experimental group
The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded.
Measured: Postoperative Day 2
Surgical plethysmographic index : time within the defined thresholds: Control group
The time during which the surgical plethysmographic index is within the defined thresholds (intraoperatively after anesthetic induction): will be collected at the end of surgery (SPI between 20 and 50)
Measured: Day 0 immediately after surgery
Surgical plethysmographic index : Time within the defined thresholds: Experimental group
The time during which the surgical plethysmographic index is within the defined thresholds (intraoperatively after anesthetic induction): will be collected at the end of surgery (SPI between 20 and 50)
Measured: Day 0 immediately after surgery
Train-of-four: Time within the defined thresholds: Control group
The time during which the train-of-four parameters are within their defined thresholds (intraoperatively after anesthetic induction): TOF > 90% will be collected at the end of surgery
Measured: Day 0 immediately after surgery
Train-of-four: Time within the defined thresholds: Experimental group
The time during which the train-of-four parameters are within their defined thresholds (intraoperatively after anesthetic induction): TOF > 90% will be collected at the end of surgery
Measured: Day 0 immediately after surgery
State entropy: time within the defined thresholds: Control group
The time during which state entropy is within the defined thresholds (intraoperatively after anesthetic induction) will be collected at the end of surgery (SE between 40 and 60)
Measured: Day 0 immediately after surgery
State entropy: Time within the defined thresholds: Experimental group
The time during which state entropy is within the defined thresholds (intraoperatively after anesthetic induction) will be collected at the end of surgery (SE between 40 and 60)
Measured: Day 0 immediately after surgery
Mean arterial pressure: Time within the defined thresholds: Control group
The time during which the mean arterial pressure is within the defined thresholds (intraoperatively after anesthetic induction) i.e. MAP > 60 mmHg will be collected at the end of surgery
Measured: Day 0 immediately after surgery
Mean arterial pressure: Time within the defined thresholds: Experimental group
The time during which the mean arterial pressure is within the defined thresholds (intraoperatively after anesthetic induction) i.e. MAP > 60 mmHg will be collected at the end of surgery
Measured: Day 0 immediately after surgery
Monitor use in the Control group
Monitor use will be defined as the prevalence (in %) of patients with simultaneous placement of SE, SPI and NMT sensors for more than 90% of the total duration of general anesthesia.
Measured: Day 0 immediately after surgery
Monitor use in the Experimental group
Monitor use will be defined as the prevalence (in %) of patients with simultaneous placement of SE, SPI and NMT sensors for more than 90% of the total duration of general anesthesia.
Measured: Day 0 immediately after surgery
Compliance with intraoperative therapeutic targets in the Control group
Compliance with intraoperative therapeutic targets will be defined as the prevalence (in %) of patients presenting the following triad: A SE between 40-60 more than 70% of the time of the maintenance phase of general anesthesia and an SPI between 20-50 more than 70% of the time of the maintenance phase of general anesthesia and TOF > 90% at extubation. These parameters will also be assessed individually.
Measured: Day 0 after surgery
Compliance with intraoperative therapeutic targets in the Experimental group
Compliance with intraoperative therapeutic targets will be defined as the prevalence (in %) of patients presenting the following triad: A SE between 40-60 more than 70% of the time of the maintenance phase of general anesthesia and an SPI between 20-50 more than 70% of the time of the maintenance phase of general anesthesia and TOF > 90% at extubation. These parameters will also be assessed individually.
Measured: Day 0 after surgery
Participation rates: state registered anesthetic nurses
Participation will be defined as the presence/viewing of at least one teaching from among video (<90% video viewing) and/or anesthesia staff (paper sign-in sheet) and/or bibliography (paper sign-in sheet) and/or in situ training (paper sign-in sheet) : The overall participation rate and participation rates per learner class will be recorded.
Measured: Day 28
Participation rates: anesthesiologist-resuscitation doctors
Participation will be defined as the presence/viewing of at least one teaching from among video (<90% video viewing) and/or anesthesia staff (paper sign-in sheet) and/or bibliography (paper sign-in sheet) and/or in situ training (paper sign-in sheet) : The overall participation rate and participation rates per learner class will be recorded.
Measured: Day 28
Participation rates: interns
Participation will be defined as the presence/viewing of at least one teaching from among video (<90% video viewing) and/or anesthesia staff (paper sign-in sheet) and/or bibliography (paper sign-in sheet) and/or in situ training (paper sign-in sheet) : The overall participation rate and participation rates per learner class will be recorded.
Measured: Day 28
Overall participation rates: state registered anesthetic nurses, anesthesiologist-resuscitation doctors and interns
Participation will be defined as the presence/viewing of at least one teaching from among video (<90% video viewing) and/or anesthesia staff (paper sign-in sheet) and/or bibliography (paper sign-in sheet) and/or in situ training (paper sign-in sheet) : An overall participation rate for all participants, whatever their learner class, will be recorded.
Measured: Day 28
Overall satisfaction rate
The overall satisfaction rate will be measured on a Likert scale in which 0 = very dissatisfied and 10 = very satisfied.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start5 Feb 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for All Conditions Requiring Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective interventional monocentric before-and-after clinical study to evaluate the impact of a "quality improvement project" intervention. The intervention consists in informing, training and coaching teams on how to use the surgical plethysmographic index, state entropy and train-of-four intraoperative monitors and AoA software.
- Masking
- None (open label)
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann GRICOURT, Doctor, Principal investigator, Nîmes University Hospital, FranceMikael PERIN, Doctor, Principal investigator, Nîmes University Hospital, FranceChristophe BOISSON, Doctor, Principal investigator, Nîmes University Hospital, FranceArianne Lannelongue, Doctor, Principal investigator, Nîmes University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111248
- Sponsor's protocol ID
- CIVI/2023/PC-01
- Acronym
- AoA QUALITY
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gricourt Y, Bibollet G, Perin M, Vialatte PB, Forget P, Alexander B, Chasseigne V, Lefrant JY, Mezzarobba M, Cuvillon P. Exploring sevoflurane consumption and CO2 emissions of individual patients undergoing noncardiac surgery using a target-controlled sevoflurane administration system. J Clin Monit Comput. 2026 Apr;40(2):439-447. doi: 10.1007/s10877-025-01370-3. Epub 2025 Oct 21.
PubMed 41118122Bernat M, Cuvillon P, Brieussel T, Roche M, Remacle A, Leone M, Lukaszewicz AC, Bouvet L, Zieleskiewicz L. The carbon footprint of general anaesthesia in adult patients: a multicentre observational comparison of intravenous and inhalation anaesthetic strategies in 35,242 procedures. Br J Anaesth. 2025 Jun;134(6):1620-1627. doi: 10.1016/j.bja.2025.01.043. Epub 2025 Apr 4.
PubMed 40187906Cuvillon P, Serrand C, Tourigny C, Lancelot P, Perin M, Bourdin L, Simon N, Boisson C, Gricourt Y. Effect of a Tailored Educational Programme on Adequacy of Anaesthesia and Major Postoperative Complications: A Before-After Quality-Improvement Study in Intermediate- and High-Risk Surgery. Anaesth Crit Care Pain Med. 2026 Oct 28:101964. doi: 10.1016/j.accpm.2026.101964. Online ahead of print.
PubMed 42951211
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Training Healthcare Teams (Quality Improvement Project) in the Combined Use of AoA Carestation Software and Digital Intraoperative Monitoring Tools (State Entropy, Surgical Pleth Index and Train-of-Four) During General Anesthesia for Intermediate- or Major-risk Surgery on Patient Morbidity and Mortality at 28 Days
- ClinicalTrials.gov ID
- NCT06111248
- Acronym / sponsor ID
- AoA QUALITY / CIVI/2023/PC-01
- Keywords
- Anesthesia, Monitoring, Cardiovascular assessment, Anesthesiology Devices, Diagnostic and Monitoring Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 1 Nov 2023 (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.
Tools such as surgical plethysmographic index, state entropy, train-of-four monitors exist to optimize the conduct of general anesthesia in intermediate and major risk surgery as defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Although these monitors are available on anesthesia machines they are still under-used by teams due to lack of training, practice and a real understanding of their usefulness (operation, expected benefits). When used in conjunction with General Electric's AoA Carestation Insight software, these tools could have a real impact on morbidity and mortality at 28 days post-op. The aim of this prospective monocentric interventional "before/after" study is to assess the impact of training and encouraging teams to use these tools.
Detailed description
Recently, complex monitoring tools (nociception by surgical plethysmographic index monitoring, curare by train-of four monitoring, depth of anesthesia by state entropy monitoring) have been developed to optimize the conduct of general anesthesia in intermediate and major risk surgery (surgery defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery). In practice, these monitors optimize nociception and the depth of anesthesia, "neither too strong nor too light". These monitors are currently available on our anesthesia machines and can be used routinely. However, these monitors are under-used by teams due to lack of training, practice and real understanding of their usefulness (operation, expected benefits).
Excess nociception and depth of anesthesia are correlated with more postoperative complications, but no studies have ever shown that the combined use of these monitors (surgical plethysmographic index, state entropy, train-of-four) could significantly reduce postoperative morbidity and mortality in patients by optimizing the management of general anesthesia. Software (AoA Carestation insight, General Electric) connected to these monitors can :
- automatically query the use of intraoperative monitors;
- perform usage audits to monitor teams' adherence to their practices;
- coach teams by encouraging them to perform anesthesia while maintaining surgical plethysmographic index (SPI), state entropy (SE) and train-of-four (TOF) values within the thresholds considered in the literature as being optimal for anesthesia (formalized expert recommendations from the SFAR (Société Francaise d'Anesthésie et de Réanimation).
In a prospective monocentric interventional "before/after" study, the aim is to assess the impact of training and encouraging teams to use the AoA Carestation Insight software in conjunction with SPI, SE and TOF monitoring, on morbidity and mortality at 28 days post-op.
The hypothesis is that training and encouraging teams ("quality improvement project") to use these intraoperative monitoring tools (SPI, TOF, SE) during general anesthesia for intermediate- or major-risk surgery could significantly reduce 28-day morbidity and mortality (composite criterion).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective interventional monocentric before-and-after clinical study to evaluate the impact of a "quality improvement project" intervention. The intervention consists in informing, training and coaching teams on how to use the surgical plethysmographic index, state entropy and train-of-four intraoperative monitors and AoA software.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –638 patients receiving the usual, standard management for anesthesia when undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk. |
| Experimental group | Experimental | Other: Training638 patients undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk who have been managed by staff trained in the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an ASA score 2-4.
- Patients due to be operated on under general anesthesia for any intermediate- or major-risk non-cardiac procedure lasting > 60 min.
- Patients affiliated to, or benefiting from, a health insurance plan.
Key exclusion criteria (11 listed)
- Patients who have indicated their refusal to participate in the study.
- Patients scheduled for minor surgery.
- Patients with an ASA score 1 or 5.
- Patients due for outpatient surgery.
- Patients due for surgery under local or locoregional anesthesia.
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 |
|---|---|---|
| TrainingStaff training on the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software. | Other | Experimental group |
Primary outcome
Occurrence of death after surgery in the control group
Time frame: Day 28
YES/NO
Occurrence of death after surgery in the experimental group
Time frame: Day 28
YES/NO
Occurence of acute myocardial infarction after surgery in the control group
Time frame: Day 28
YES/NO
Occurence of acute myocardial infarction after surgery in the experimental group
Time frame: Day 28
YES/NO
Occurence of arterial or venous thrombosis after surgery in the control group
Time frame: Day 28
YES/NO
Occurence of arterial or venous thrombosis after surgery in the experimental group
Time frame: Day 28
YES/NO
Occurence of a stroke after surgery in the control group
Time frame: Day 28
YES/NO
Occurence of a stroke after surgery in the experimental group
Time frame: Day 28
YES/NO
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the control group
Time frame: Day 28
YES/NO
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the experimental group
Time frame: Day 28
YES/NO
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the control group
Time frame: Day 28
YES/NO
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the experimental group
Time frame: Day 28
YES/NO
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the control group
Time frame: Day 28
YES/NO
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the experimental group
Time frame: Day 28
YES/NO
Postoperative episodes of sepsis and infections (according to the 2001 international definitions of sepsis) in the control group
Time frame: Day 28
YES/NO
Post-operative respiratory complications: defined as the need for intubation and/or non-invasive ventilation in the event of respiratory failure in the control group
Time frame: Day 28
YES/NO
Acute kidney injury in the control group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
Time frame: Day 28
YES/NO
Acute kidney injury in the experimental group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
Time frame: Day 28
YES/NO
Surgical complications in the control group: need for re-operation for any reason and radiological intervention for abscess drainage
Time frame: Day 28
YES/NO
Surgical complications in the experimental group: need for re-operation for any reason and radiological intervention for abscess drainage
Time frame: Day 28
YES/NO
Unplanned admission or readmission to the intensive care unit: control group
Time frame: Day 28
YES/NO
Unplanned admission or readmission to the intensive care unit: experimental group
Time frame: Day 28
YES/NO
49 secondary outcomes
Length of hospital stay : Control group
Time frame: Day 28
Length of hospital stay : Experimental group
Time frame: Day 28
Length of stay (hours) in the post-procedure care department : Control group
Time frame: Day 28
Length of stay (hours) in the post-procedure care department : Experimental group
Time frame: Day 28
Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Control group
Time frame: Day 28
Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Experimental group
Time frame: Day 28
Number of episodes of nausea/vomiting up to 12 hours after surgery: Control group
Time frame: 12 hours post-surgery
Number of episodes of nausea/vomiting up to 24 hours after surgery: Control group
Time frame: 24 hours post-surgery
Number of episodes of nausea/vomiting up to 48 hours after surgery: Control group
Time frame: 48 hours post-surgery
Number of episodes of nausea/vomiting up to 12 hours after surgery: Experimental group
Time frame: 12 hours post-surgery
Number of episodes of nausea/vomiting up to 24 hours after surgery: Experimental group
Time frame: 24 hours post-surgery
Number of episodes of nausea/vomiting up to 48 hours after surgery: Experimental group
Time frame: 48 hours post-surgery
Post-surgical pain at 6 hours as measured by the Control group
Time frame: At 6 hours post-surgery
Post-surgical pain at 6 hours as measured by the Experimental group
Time frame: At 6 hours post-surgery
Post-surgical pain at 12 hours as measured by the Control group
Time frame: At 12 hours post-surgery
Post-surgical pain at 12 hours as measured by the Experimental group
Time frame: At 12 hours post-surgery
Post-surgical pain at 18 hours as measured by the Control group
Time frame: At 18 hours post-surgery
Post-surgical pain at 18 hours as measured by the Experimental group
Time frame: At 18 hours post-surgery
Post-surgical pain at 24 hours as measured by the Control group
Time frame: At 24 hours post-surgery
Post-surgical pain at 24 hours as measured by the Experimental group
Time frame: At 24 hours post-surgery
Post-surgical pain at 30 hours as measured by the Control group
Time frame: At 30 hours post-surgery
Post-surgical pain at 30 hours as measured by the Experimental group
Time frame: At 30 hours post-surgery
Post-surgical pain at 36 hours as measured by the Control group
Time frame: At 36 hours post-surgery
Post-surgical pain at 36 hours as measured by the Experimental group
Time frame: At 36 hours post-surgery
Post-surgical pain at 42 hours as measured by the Control group
Time frame: At 42 hours post-surgery
Post-surgical pain at 42 hours as measured by the Experimental group
Time frame: At 42 hours post-surgery
Post-surgical pain at 48 hours as measured by the Control group
Time frame: At 48 hours post-surgery
Post-surgical pain at 48 hours as measured by the Experimental group
Time frame: At 48 hours post-surgery
Confusion : Control group
Time frame: Postoperative Day 1
Confusion : Control group
Time frame: Postoperative Day 2
Confusion : Experimental group
Time frame: Postoperative Day 1
Confusion : Experimental group
Time frame: Postoperative Day 2
Surgical plethysmographic index : time within the defined thresholds: Control group
Time frame: Day 0 immediately after surgery
Surgical plethysmographic index : Time within the defined thresholds: Experimental group
Time frame: Day 0 immediately after surgery
Train-of-four: Time within the defined thresholds: Control group
Time frame: Day 0 immediately after surgery
Train-of-four: Time within the defined thresholds: Experimental group
Time frame: Day 0 immediately after surgery
State entropy: time within the defined thresholds: Control group
Time frame: Day 0 immediately after surgery
State entropy: Time within the defined thresholds: Experimental group
Time frame: Day 0 immediately after surgery
Mean arterial pressure: Time within the defined thresholds: Control group
Time frame: Day 0 immediately after surgery
Mean arterial pressure: Time within the defined thresholds: Experimental group
Time frame: Day 0 immediately after surgery
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 23 Jan 2026.
- Background: PubMed 41118122Gricourt Y, Bibollet G, Perin M, Vialatte PB, Forget P, Alexander B, Chasseigne V, Lefrant JY, Mezzarobba M, Cuvillon P. Exploring sevoflurane consumption and CO2 emissions of individual patients undergoing noncardiac surgery using a target-controlled sevoflurane administration system. J Clin Monit Comput. 2026 Apr;40(2):439-447. doi: 10.1007/s10877-025-01370-3. Epub 2025 Oct 21.
- Results publication: PubMed 40187906Bernat M, Cuvillon P, Brieussel T, Roche M, Remacle A, Leone M, Lukaszewicz AC, Bouvet L, Zieleskiewicz L. The carbon footprint of general anaesthesia in adult patients: a multicentre observational comparison of intravenous and inhalation anaesthetic strategies in 35,242 procedures. Br J Anaesth. 2025 Jun;134(6):1620-1627. doi: 10.1016/j.bja.2025.01.043. Epub 2025 Apr 4.
- Derived from this study: PubMed 42951211Cuvillon P, Serrand C, Tourigny C, Lancelot P, Perin M, Bourdin L, Simon N, Boisson C, Gricourt Y. Effect of a Tailored Educational Programme on Adequacy of Anaesthesia and Major Postoperative Complications: A Before-After Quality-Improvement Study in Intermediate- and High-Risk Surgery. Anaesth Crit Care Pain Med. 2026 Oct 28:101964. doi: 10.1016/j.accpm.2026.101964. Online ahead of print.
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.
Yann GRICOURT, Doctor principal investigator
Nîmes University Hospital, France
Mikael PERIN, Doctor principal investigator
Nîmes University Hospital, France
Christophe BOISSON, Doctor principal investigator
Nîmes University Hospital, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with All Conditions Requiring Non-cardiac Surgery, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 11 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 23 Jan 2026. 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?
Occurrence of death after surgery in the control group (time frame: Day 28). The study lists 22 primary outcomes in all. 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 NCT06111248, which also lists 3 linked publications.
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 23 Jan 2026.