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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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All Conditions Requiring Non-cardiac Surgery

Intervention / Treatment
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* Other: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>638 patients receiving the usual, standard management for anesthesia when undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk. | |
| Experimental: Experimental group<br>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. | Other: Training<br>* Staff training on the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of death after surgery in the control group | YES/NO | Day 28 | 
| Occurrence of death after surgery in the experimental group | YES/NO | Day 28 | 
| Occurence of acute myocardial infarction after surgery in the control group | YES/NO | Day 28 | 
| Occurence of acute myocardial infarction after surgery in the experimental group | YES/NO | Day 28 | 
| Occurence of arterial or venous thrombosis after surgery in the control group | YES/NO | Day 28 | 
| Occurence of arterial or venous thrombosis after surgery in the experimental group | YES/NO | Day 28 | 
| Occurence of a stroke after surgery in the control group | YES/NO | Day 28 | 
| Occurence of a stroke after surgery in the experimental group | YES/NO | Day 28 | 
| Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the control group | YES/NO | Day 28 | 
| Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the experimental group | YES/NO | Day 28 | 
| Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the control group | YES/NO | Day 28 | 
| Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the experimental group | YES/NO | Day 28 | 
| Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the control group | YES/NO | Day 28 | 
| Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the experimental group | YES/NO | Day 28 | 
| Postoperative episodes of sepsis and infections (according to the 2001 international definitions of sepsis) in the control group | YES/NO | 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 | 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 | 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 | Day 28 | 
| Surgical complications in the control group: need for re-operation for any reason and radiological intervention for abscess drainage | YES/NO | Day 28 | 
| Surgical complications in the experimental group: need for re-operation for any reason and radiological intervention for abscess drainage | YES/NO | Day 28 | 
| Unplanned admission or readmission to the intensive care unit: control group | YES/NO | Day 28 | 
| Unplanned admission or readmission to the intensive care unit: experimental group | YES/NO | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Postoperative Day 1 | 
| Confusion : Control group | The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded. | Postoperative Day 2 | 
| Confusion : Experimental group | The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded. | Postoperative Day 1 | 
| Confusion : Experimental group | The number of episodes of confusion according to the Confusion Assessment Method, criterion 4 (disorientation) will be recorded. | 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) | 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) | 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 | 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 | 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) | 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) | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Monitoring, Cardiovascular assessment, Anesthesiology Devices, Diagnostic and Monitoring Devices