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Набор скоро начнётся NCT07721038

A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period

— Наблюдательное Brain Health

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: Brain Health. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
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Официальное название

Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health

Обзор

This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.

Первичные конечные точки

  • Concentration of cognitive function biomarkers in the serum samples of 400 patients [Срок оценки: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)]
  • Concentrations of HPA axis-related indicators in the serum samples of 400 patients [Срок оценки: Before the start of the surgery (T1), at the end of the surgery (T2)]
  • The concentrations of laboratory test indicators in the serum samples of 400 patients [Срок оценки: Before the start of the surgery (T1), and on the first day after the surgery (T3)]
Вторичные конечные точки (7)
  • Anesthesia Record Form [Срок оценки: at the end of the surgery (T2)]
  • Case information system collection [Срок оценки: Before the start of the surgery (T1), and on the first day after the surgery (T3)]
  • Anesthesia Record Form [Срок оценки: During the operation]
  • Postoperative follow-up records [Срок оценки: through study completion, an average of 1 year]
  • Postoperative follow-up records [Срок оценки: through study completion, an average of 1 year]
  • Postoperative follow-up records [Срок оценки: through study completion, an average of 1 year]
  • Postoperative follow-up records [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Patient age: 18 - 75 years old
  • Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
  • Body Mass Index (BMI) < 30 kg/m2
  • Intraoperative blood loss less than 300 ml
  • No severe cardiac or pulmonary dysfunction \[first-second forced vital capacity (FEV1%) predicted value\] > 50%, ejection fraction (EF) > 50%
  • No contraindications related to paravertebral nerve block and intercostal nerve block
  • Able to sign the informed consent form and possess communication, reading and writing abilities
  • Postoperative hospital stay of at least one day
  • No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)

Критерии исключения

  • Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
  • History of opioid abuse
  • Patients who were admitted to the ICU after surgery
  • Have severe cardiovascular, respiratory diseases
  • Experienced critical rescue during or after the surgery
  • Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
  • Difficult airway management
  • Changed anesthetic agent or surgical plan
  • Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
  • Changed anesthetic agent or surgical plan during the surgery;

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • the First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07721038 · ES-2025-216-02 · GMUCR2025-02011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗