NCT06111248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

October 20, 2023

Last Update Submit

January 21, 2026

Conditions

All Conditions Requiring Non-cardiac Surgery

Keywords

AnesthesiaMonitoringCardiovascular assessmentAnesthesiology DevicesDiagnostic and Monitoring Devices

Outcome Measures

Primary Outcomes (22)

  • 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 Outcomes (49)

  • Length of hospital stay : Control group

    Day 28

  • Length of hospital stay : Experimental group

    Day 28

  • Length of stay (hours) in the post-procedure care department : Control group

    Day 28

  • Length of stay (hours) in the post-procedure care department : Experimental group

    Day 28

  • Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Control group

    Day 28

  • +44 more secondary outcomes

Other Outcomes (18)

  • Patient's age

    Day 0

  • Patient's weight

    Day 0

  • Patient's height

    Day 0

  • +15 more other outcomes

Study Arms (2)

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.

Other: Training

Interventions

TrainingOTHER

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

Experimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 under court protection, guardianship or curatorship.
  • Patients for whom it is impossible to provide clear information.
  • Pregnant, parturient or breast-feeding patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

Related Publications (2)

  • 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. 2025 Oct 21. doi: 10.1007/s10877-025-01370-3. Online ahead of print.

    PMID: 41118122BACKGROUND

  • Bernat 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.

    PMID: 40187906RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yann GRICOURT, Doctor

    Nîmes University Hospital, France

    PRINCIPAL INVESTIGATOR

  • Mikael PERIN, Doctor

    Nîmes University Hospital, France

    PRINCIPAL INVESTIGATOR

  • Christophe BOISSON, Doctor

    Nîmes University Hospital, France

    PRINCIPAL INVESTIGATOR

  • Arianne Lannelongue, Doctor

    Nîmes University Hospital, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 1, 2023

Study Start

February 5, 2024

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

FR(1)