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Набор скоро начнётся NCT07108218

Lateral Positioning for Extubation After Adenotonsillectomy

Без фазы С лечением Perioperative Respiratory Adverse Events Adenoidectomy Tonsillectomy Children

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: lateral postion, supine position.
Кому может быть актуально
Состояния в реестре: Perioperative Respiratory Adverse Events, Adenoidectomy, Tonsillectomy, Children. Базовые параметры: 1 год — 6 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

Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial

Обзор

The postoperative recovery period following general anesthesia has been associated with a 30%-50% incidence of postoperative respiratory adverse events (PRAEs) in pediatric populations, including laryngospasm, airway obstruction, and hypoxemia. Despite the limited effects of existing pharmacological and operative interventions, positional optimization (e.g., lateral or semirecumbent position) may play a potential role by decreasing airway resistance and improving oxygenation. However, evidence-based evidence for its use in pediatric populations is still lacking, necessitating the urgent need for randomized controlled trials.

Подробное описание

This study is a multi-center, prospective, RCT conducted at four tertiary hospitals in China. It will be planned to include 350 subjects who meet the inclusion criteria and will be randomly divided into the lateral position and supine position group in a 1:1 ratio by the method of block group randomization stratified by centers. In the supine position group, the children will be extubated at the end of the procedure and observed in the decubitus position until the patient's Aldrete score was \>9 and they left the PACU, whereas in the lateral position group, the children will be extubated and observed in the head-up 30° lateral position. The primary outcome is the incidence of PRAEs. Secondary outcomes included frequency of PRAE, number of airway devices used during the postoperative recovery period, time to tracheal extubation, length of stay in the recovery room, and incidence of PRAE at 24 hours and 7 days. postoperatively. Safety outcomes include the incidence of peripheral IV access dislodgement, monitoring device detachment rate, and patient falls rate. Exploratory outcomes comprise pain levels (assessed via the FLACC scale), agitation scores (PAED scale), sedation scores (Ramsay scale), and PONV scores, all evaluated at postoperative extubation and PACU discharge.

Вмешательства

  • Процедура lateral postion
    The children will be positioned on their sides with their heads elevated by 30°, a thin pillow behind their backs, the upper legs bent, and the lower legs straightened.
  • Процедура supine position
    The children will be changed to a supine flat-lying position for extubation.

Первичные конечные точки

  • the occurrence of postoperative respiratory adverse events (PRAEs) [Срок оценки: during PACU]
Вторичные конечные точки (7)
  • Frequency of PRAEs [Срок оценки: during PACU]
  • Number of Emergency Airway Interventions [Срок оценки: during PACU]
  • Tracheal extubation time [Срок оценки: during PACU]
  • PACU stay duration [Срок оценки: during PACU]
  • Length of hospital stay [Срок оценки: postoperative day 1]
  • The PRAEs at 24 hours after surgery [Срок оценки: at 24 hours postoperatively]
  • The PRAEs at 7 days after surgery [Срок оценки: at 7 days postoperatively]

Критерии участия

Критерии включения

  • Subjects aged 1-6 years old without gender limit.
  • Scheduled for an ambulatory adenotonsillectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) classification grade I or II.
  • Informed consent obtained from the patients' parents or legal guardians, who have expressed willingness to cooperate.

Критерии исключения

  • Presence of concomitant cardiac or pulmonary dysfunction or other significant systemic comorbidities.
  • History of difficult airway management or congenital/acquired structural anomalies of the airway.
  • Active respiratory tract infection within 30 days preceding surgery.
  • Preoperative neurological disorders or developmental abnormalities.
  • Intraoperative occurrence of major complications necessitating deviation from the planned anesthesia protocol or surgical procedure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • West China Hospital — Чэнду

Идентификаторы

NCT: NCT07108218 · 2025HX880

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗