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Recruiting NCT05440331

Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

— Observational Major Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training with AnesList©.
Who it may be relevant to
Registry conditions: Major Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Overview

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.

Interventions

  • Other Training with AnesList©
    Training with AnesList© as tool

Primary outcome measures

  • The occurence of adverse events [Time frame: at 1 month]
Secondary outcome measures (7)
  • The duration of ICU stay [Time frame: through study completion, an average of 18 months]
  • The duration of hospitalization [Time frame: through study completion, an average of 18 months]
  • Evaluate of the condition of transmission [Time frame: through study completion, an average of 18 months]
  • Utilization of the AnesList© by anaesthesists at 6 months [Time frame: at 6 months]
  • Quality of medical transmission [Time frame: through study completion, an average of 18 months]
  • Interaction with study nurse [Time frame: through study completion, an average of 18 months]
  • Morbi-mortality [Time frame: through study completion, an average of 18 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP — Boulogne-Billancourt

Publications

  • Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available. PMID 26341898
  • Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636. PMID 28437261
  • Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14. PMID 19144931

Identifiers

NCT: NCT05440331 · APHP210992 · 2022-A01109-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗