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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,028 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• All Conditions Requiring Non-cardiac Surgery

Interventions

Type	Name	Description
OTHER	Training	Staff training on the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software.

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2023-11-01
• Last updated: 2026-01-23

Locations

1 site across 1 country: France