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 (AoA QUALITY)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: All Conditions Requiring Non-cardiac Surgery

Treatments: Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06111248

CIVI/2023/PC-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,028 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,028 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Training