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Идёт набор NCT05440331

Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

— Наблюдательное Major Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Training with AnesList©.
Кому может быть актуально
Состояния в реестре: Major Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Training with AnesList©
    Training with AnesList© as tool

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT05440331 · APHP210992 · 2022-A01109-34

Первоисточники (государственные реестры)

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