Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

Recruiting

• Conditions: Major Surgery
• Interventions: Other: Training with AnesList©

• Registration Number: NCT05440331
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

Detailed Description

The secondary objectives are:

* to analysis the impact of the transmission on:

1. the occurence of different events: re-hospitalization, serious complications, death at one month;

2. the duration of initial ICU stay and of hospitalization;

3. the duration of the transmission;

4. the quality of the transmission by the physician leaving operating room.

* to evaluate the condition of the transmission

* to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center

* to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization

* to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Status Verified: 2023-09
• Study Start: 2023-09-08
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1120

Inclusion Criteria

• Patient aged > 18 years;
• Patients with score ASA I-IV;
• Requiring urgent or planned surgery;
• Major surgery (duration of surgery > 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery;
• Handover between two anesthesists defined as a definitive relay between one physician anaesthesist and another in operating room;
• Intensive care anesthesists and nurse anaesthetist working in investigator center during the study;
• Affiliated to a social security system;
• No-opposition to participating to the study.

Exclusion Criteria

• Transmission between physician anaesthesist and nurse anaesthetist;
• Medical transmission occurs out of anesthesia care out of operating room;
• Medical transmission occurs in transitory manner (for example: coffee time, lunch time);
• Patients enrolled in an another ongoing study of surgical intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group with delayed training	Training with AnesList©	Control group with training: the training will delayed from time of randomization
Experimental group	Training with AnesList©	Experimental group with training after randomization immediately

Primary Outcome Measures

Name	Time	Method
The occurence of adverse events	at 1 month	Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.

Secondary Outcome Measures

Name	Time	Method
Evaluate of the condition of transmission	through study completion, an average of 18 months	By the presence or intervention of anaesthetics-nurse, recorded or not the transmission in medical files.
Morbi-mortality	through study completion, an average of 18 months	The method of chronological series will be used to analysis the morbi-mortality in investigator center.
The duration of ICU stay	through study completion, an average of 18 months	The length of initial ICU stay will be noted.
The duration of hospitalization	through study completion, an average of 18 months	The length of initial hospitalization will be noted.
Utilization of the AnesList© by anaesthesists at 6 months	at 6 months	Only for intervention group: use on cell phone or with printed form: the use will be noted.
Interaction with study nurse	through study completion, an average of 18 months	The study nurse will evaluate the existence and composite of the interaction between the anesthesist who receiving the transmission and the nurse.
Quality of medical transmission	through study completion, an average of 18 months	Scale will be noted by anaesthesists between 0 and 22: 20% of recorded transmission will be noted.

Trial Locations

Locations (1)

Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP; 🇫🇷 Boulogne-Billancourt, France