Clinical trial NCT06111248: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Conditions Requiring Non-cardiac Surgery
Keywords: Anesthesia
Monitoring
Cardiovascular assessment
Anesthesiology Devices
Diagnostic and Monitoring Devices
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 1028
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of death after surgery in the control group
timeFrame: Day 28
measure: Occurrence of death after surgery in the experimental group
timeFrame: Day 28
measure: Occurence of acute myocardial infarction after surgery in the control group
timeFrame: Day 28
measure: Occurence of acute myocardial infarction after surgery in the experimental group
timeFrame: Day 28
measure: Occurence of arterial or venous thrombosis after surgery in the control group
timeFrame: Day 28
measure: Occurence of arterial or venous thrombosis after surgery in the experimental group
timeFrame: Day 28
measure: Occurence of a stroke after surgery in the control group
timeFrame: Day 28
measure: Occurence of a stroke after surgery in the experimental group
timeFrame: Day 28
measure: Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the control group
timeFrame: Day 28
measure: Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the experimental group
timeFrame: Day 28
measure: Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the control group
timeFrame: Day 28
measure: Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the experimental group
timeFrame: Day 28
measure: Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the control group
timeFrame: Day 28
measure: Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the experimental group
timeFrame: Day 28
measure: Postoperative episodes of sepsis and infections (according to the 2001 international definitions of sepsis) in the control group
timeFrame: Day 28
measure: 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
timeFrame: Day 28
measure: Acute kidney injury in the control group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
timeFrame: Day 28
measure: Acute kidney injury in the experimental group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
timeFrame: Day 28
measure: Surgical complications in the control group: need for re-operation for any reason and radiological intervention for abscess drainage
timeFrame: Day 28
measure: Surgical complications in the experimental group: need for re-operation for any reason and radiological intervention for abscess drainage
timeFrame: Day 28
measure: Unplanned admission or readmission to the intensive care unit: control group
timeFrame: Day 28
measure: Unplanned admission or readmission to the intensive care unit: experimental group
timeFrame: Day 28
Secondary outcomes:
measure: Length of hospital stay : Control group
timeFrame: Day 28
measure: Length of hospital stay : Experimental group
timeFrame: Day 28
measure: Length of stay (hours) in the post-procedure care department : Control group
timeFrame: Day 28
measure: Length of stay (hours) in the post-procedure care department : Experimental group
timeFrame: Day 28
measure: Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Control group
timeFrame: Day 28
measure: Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Experimental group
timeFrame: Day 28
measure: Number of episodes of nausea/vomiting up to 12 hours after surgery: Control group
timeFrame: 12 hours post-surgery
measure: Number of episodes of nausea/vomiting up to 24 hours after surgery: Control group
timeFrame: 24 hours post-surgery
measure: Number of episodes of nausea/vomiting up to 48 hours after surgery: Control group
timeFrame: 48 hours post-surgery
measure: Number of episodes of nausea/vomiting up to 12 hours after surgery: Experimental group
timeFrame: 12 hours post-surgery
measure: Number of episodes of nausea/vomiting up to 24 hours after surgery: Experimental group
timeFrame: 24 hours post-surgery
measure: Number of episodes of nausea/vomiting up to 48 hours after surgery: Experimental group
timeFrame: 48 hours post-surgery
measure: Post-surgical pain at 6 hours as measured by the Control group
timeFrame: At 6 hours post-surgery
measure: Post-surgical pain at 6 hours as measured by the Experimental group
timeFrame: At 6 hours post-surgery
measure: Post-surgical pain at 12 hours as measured by the Control group
timeFrame: At 12 hours post-surgery
measure: Post-surgical pain at 12 hours as measured by the Experimental group
timeFrame: At 12 hours post-surgery
measure: Post-surgical pain at 18 hours as measured by the Control group
timeFrame: At 18 hours post-surgery
measure: Post-surgical pain at 18 hours as measured by the Experimental group
timeFrame: At 18 hours post-surgery
measure: Post-surgical pain at 24 hours as measured by the Control group
timeFrame: At 24 hours post-surgery
measure: Post-surgical pain at 24 hours as measured by the Experimental group
timeFrame: At 24 hours post-surgery
measure: Post-surgical pain at 30 hours as measured by the Control group
timeFrame: At 30 hours post-surgery
measure: Post-surgical pain at 30 hours as measured by the Experimental group
timeFrame: At 30 hours post-surgery
measure: Post-surgical pain at 36 hours as measured by the Control group
timeFrame: At 36 hours post-surgery
measure: Post-surgical pain at 36 hours as measured by the Experimental group
timeFrame: At 36 hours post-surgery
measure: Post-surgical pain at 42 hours as measured by the Control group
timeFrame: At 42 hours post-surgery
measure: Post-surgical pain at 42 hours as measured by the Experimental group
timeFrame: At 42 hours post-surgery
measure: Post-surgical pain at 48 hours as measured by the Control group
timeFrame: At 48 hours post-surgery
measure: Post-surgical pain at 48 hours as measured by the Experimental group
timeFrame: At 48 hours post-surgery
measure: Confusion : Control group
timeFrame: Postoperative Day 1
measure: Confusion : Control group
timeFrame: Postoperative Day 2
measure: Confusion : Experimental group
timeFrame: Postoperative Day 1
measure: Confusion : Experimental group
timeFrame: Postoperative Day 2
measure: Surgical plethysmographic index : time within the defined thresholds: Control group
timeFrame: Day 0 immediately after surgery
measure: Surgical plethysmographic index : Time within the defined thresholds: Experimental group
timeFrame: Day 0 immediately after surgery
measure: Train-of-four: Time within the defined thresholds: Control group
timeFrame: Day 0 immediately after surgery
measure: Train-of-four: Time within the defined thresholds: Experimental group
timeFrame: Day 0 immediately after surgery
measure: State entropy: time within the defined thresholds: Control group
timeFrame: Day 0 immediately after surgery
measure: State entropy: Time within the defined thresholds: Experimental group
timeFrame: Day 0 immediately after surgery
measure: Mean arterial pressure: Time within the defined thresholds: Control group
timeFrame: Day 0 immediately after surgery
measure: Mean arterial pressure: Time within the defined thresholds: Experimental group
timeFrame: Day 0 immediately after surgery
measure: Monitor use in the Control group
timeFrame: Day 0 immediately after surgery
measure: Monitor use in the Experimental group
timeFrame: Day 0 immediately after surgery
measure: Compliance with intraoperative therapeutic targets in the Control group
timeFrame: Day 0 after surgery
measure: Compliance with intraoperative therapeutic targets in the Experimental group
timeFrame: Day 0 after surgery
measure: Participation rates: state registered anesthetic nurses
timeFrame: Day 28
measure: Participation rates: anesthesiologist-resuscitation doctors
timeFrame: Day 28
measure: Participation rates: interns
timeFrame: Day 28
measure: Overall participation rates: state registered anesthetic nurses, anesthesiologist-resuscitation doctors and interns
timeFrame: Day 28
measure: Overall satisfaction rate
timeFrame: Day 28
Other outcomes:
measure: Patient's age
timeFrame: Day 0
measure: Patient's weight
timeFrame: Day 0
measure: Patient's height
timeFrame: Day 0
measure: Patient's body mass index
timeFrame: Day 0
measure: Patient's ASA (American Society of Anesthesiologists) score
timeFrame: Day 0
measure: Patient's pre-operative comorbidities and associated treatments
timeFrame: Day 0
measure: Patient's Lee score
timeFrame: Day 0
measure: Date of surgery
timeFrame: Day 0
measure: Type of surgery
timeFrame: Day 0
measure: Duration of surgery
timeFrame: Day 0
measure: Anesthesia: airway access
timeFrame: Day 0
measure: Blood loss
timeFrame: Day 0
measure: Anesthesic agents
timeFrame: Day 0
measure: pre- and intraoperative haemodynamic parameters: MAP
timeFrame: Day 0
measure: pre- and intraoperative haemodynamic parameters: heart rate
timeFrame: Day 0
measure: Patient's post-operative pain
timeFrame: Day 0
measure: Thromboprophylaxis
timeFrame: Day 0
measure: Antibioprophylaxis
timeFrame: Day 0
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: Nîmes University Hospital, France
name: Yann GRICOURT, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital, France
name: Mikael PERIN, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital, France
name: Christophe BOISSON, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital, France
name: Arianne Lannelongue, Doctor
role: PRINCIPAL_INVESTIGATOR
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