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Идёт набор NCT06296277

Mechanical Ventilation in Surgical Patients

Наблюдательное Surgery Ventilator Lung Postoperative Complications

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: Intraoperative mechanical ventilation for surgery.
Кому может быть актуально
Состояния в реестре: Surgery, Ventilator Lung, Postoperative Complications. 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry

Обзор

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation. Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

Подробное описание

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study The here proposed study aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded.

The primary endpoint is to report the number of patients with PPCs occurring in the first 5 postoperative days. As secondary endpoint, the practice of mechanical ventilation in patients undergoing general anesthesia for surgery will be ascertained including key intraoperative ventilator characteristics and respiratory system mechanics. Other secondary endpoints will include: incidence and type of IAEs; postoperative complications other than PPCs in the first 5 postoperative days; intensive care unit (ICU) admission and length of stay, hospital length of stay, and hospital mortality on day 28.

Participating hospitals have the flexibility to choose a specific time period for data collection, but it is imperative that this process occurs within 8 weeks from receiving approval by the local Ethics Committee. Furthermore, each participating center will conduct data collection during a predetermined 7-day period. Local investigators will capture data in an electronic case recording form, including patient demographics and baseline characteristics, intraoperative ventilator settings and ventilation parameters, and outcomes.

Вмешательства

  • Другое Intraoperative mechanical ventilation for surgery
    Any IMV during general anesthesia for surgery

Первичные конечные точки

  • Postoperative pulmonary complications (PPCs) [Срок оценки: within 5 days after surgery]
Вторичные конечные точки (3)
  • Intraoperative adverse events (IAEs) [Срок оценки: Intraoperatively]
  • Intraoperative mechanical ventilation practice [Срок оценки: Intraoperatively]
  • Postoperative clinical outcome [Срок оценки: Postoperatively, on day 28 following surgery]

Критерии участия

Критерии включения

  • Adults; and
  • Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery

Критерии исключения

  • Receiving intraoperative IMV outside of an operating room; and
  • Receiving intraoperative IMV during extracorporeal life support

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Azienda Ospedaliero Universitaria di Alessandria — Alessandria

Идентификаторы

NCT: NCT06296277 · UPO#1!

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗