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Идёт набор NCT07672106

Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients

— Наблюдательное Postoperative Respiratory Failure Extubation Failure Lung Ultrasonography Score Diaphragm Thickness

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Respiratory Failure, Extubation Failure, Lung Ultrasonography Score, Diaphragm Thickness. 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
Turkey (Türkiye)
Следующий шаг
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Обзор

This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Reintubation after extubation is an important clinical problem because it may increase complications, prolong mechanical ventilation, and extend intensive care and hospital stay. The study will include adult patients who are extubated in the operating room and admitted to the intensive care unit with spontaneous breathing. Within the first hours after ICU admission, bedside ultrasound measurements of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score will be performed. The ROX index will also be calculated using oxygen saturation, inspired oxygen concentration, and respiratory rate. Perioperative fluid balance will be recorded from anesthesia and patient files. Patients will be followed for 48 to 72 hours after ICU admission to determine whether reintubation is required. The study aims to assess whether respiratory muscle ultrasound findings, lung ultrasound score, ROX index, and perioperative fluid balance can help predict reintubation risk in postoperative ICU patients. No additional treatment or intervention will be applied as part of the study, and all clinical decisions will be made by the responsible intensive care team according to routine clinical practice.

Первичные конечные точки

  • Reintubation Within 72 Hours After Intensive Care Unit Admission [Срок оценки: From intensive care unit admission to 72 hours after admission]
Вторичные конечные точки (3)
  • Diaphragm Thickness at Intensive Care Unit Admission [Срок оценки: Within 0-30 minutes after intensive care unit admission]
  • Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission [Срок оценки: Within 0-30 minutes after intensive care unit admission]
  • Lung Ultrasound Score at Intensive Care Unit Admission [Срок оценки: Within 0-30 minutes after intensive care unit admission]

Критерии участия

Критерии включения

Adult patients aged 18 years and older

Patients requiring postoperative intensive care follow-up after major surgery, including abdominal, vascular, orthopedic, or ear, nose, throat, head and neck surgery

Patients extubated in the operating room and admitted to the intensive care unit with spontaneous breathing

Patients without any clinical condition preventing the planned measurements within the first 0-2 hours after ICU admission (T0 and T1)

Patients for whom written informed consent can be obtained from the patient or legally authorized representative

Patients admitted to the intensive care unit within the specified study period after ethics committee approval and enrolled consecutively

Критерии исключения

Patients younger than 18 years of age

Patients who leave the operating room intubated or are admitted to the intensive care unit while intubated

Patients with a tracheostomy

Patients with a history of diaphragmatic paralysis

Patients with a significant neuromuscular disease, such as ALS, myasthenia gravis, or similar conditions

Patients with conditions that significantly prevent ultrasound measurements, including marked subcutaneous emphysema, large dressings or bandages covering the measurement area, inability to access the measurement site due to drains or the surgical field, or inability to obtain technically adequate images

Patients in whom the planned measurements cannot be performed due to clinical instability requiring emergency intubation immediately after ICU admission

Patients from whom informed consent cannot be obtained, or patients or legally authorized representatives who refuse participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi — Istanbul

Публикации

  • Hattori J, Tanaka A, Kosaka J, Hirao O, Furushima N, Maki Y, Kabata D, Uchiyama A, Egi M, Morimatsu H, Mizobuchi S, Kotake Y, Shintani A, Koyama Y, Yoshida T, Fujino Y. Clinical predictors of extubation failure in postoperative critically ill patients: a post-hoc analysis of a multicenter prospective observational study. BMC Anesthesiol. 2025 Mar 15;25(1):127. doi: 10.1186/s12871-025-02996-1. PMID 40089666
  • Masaki H, Suzuki S, Nakayama N, Kobayashi E, Fujii A, Nishiwaki K, Mizuno M, Nakatochi M. Risk markers for postoperative reintubation of intensive care unit patients: A retrospective multicentre study of the National Intensive Care Registry. Intensive Crit Care Nurs. 2025 Apr;87:103956. doi: 10.1016/j.iccn.2025.103956. Epub 2025 Feb 3. PMID 39904074

Идентификаторы

NCT: NCT07672106 · 312923028

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗