Набор скоро начнётся NCT07293286

Effect of Different Oxygen Concentrations Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit

Без фазы С лечением Hypoxemia

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: 100% oxygen concentration inhaled, 30% oxygen concentration inhaled.
Кому может быть актуально: Состояния в реестре: Hypoxemia. Базовые параметры: 18 лет — 65 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Different Oxygen Concentrations During the Recovery Period Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit

Обзор

Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation. However, even inhaling a short period of pure oxygen can cause absorptive atelectasis, and may even impair the effectiveness of intraoperative protective ventilation measures continuing to post-operative period. The purpose of this study is to determine whether 30% oxygen before extubation after abdominal surgery could reduce hypoxemia incidence after extubation during the recovery period or not, compared to 100% oxygen. 590 patients scheduled to abdominal surgeries, will be randomly assigned to receive 30% or 100% oxygen concentration from the end of surgery to extubation after general anesthesia in the post-anesthesia care unit. The incidence of hypoxemia (SpO2 \< 90%) from extubation to leaving the post-anesthesia care unit (PACU) is the primary outcome.

Вмешательства

Другое 100% oxygen concentration inhaled
Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 100%.
Другое 30% oxygen concentration inhaled
Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 30%.

Первичные конечные точки

Incidence of hypoxemia [Срок оценки: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit]

Вторичные конечные точки (10)

Incidence of post operative pulmonary-related complications [Срок оценки: Within 7 days after surgery]
Incidence of severe hypoxemia [Срок оценки: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit]
Arterial partial pressure of oxygen (PaO2) [Срок оценки: At the day of surgery after tracheal extubation in the post-anesthesia care unit]
Score of lung ultrasound [Срок оценки: At the day of surgery after tracheal extubation in the post-anesthesia care unit]
Area of atelectasis shown on chest CT [Срок оценки: At the day of surgery after tracheal extubation]
Number of patients unplanned transfers to the ICU [Срок оценки: 30 days after surgery]
Length of postoperative stay [Срок оценки: At hospital discharge]
Number of patients return to the hospital after discharge [Срок оценки: 30 days after surgery]
Number of deaths [Срок оценки: 30 days after surgery]
Number of patients with important organ disfunction after surgery, including arrhythmia, acute myocardial injury, heart failure, renal function injury, liver function injury, and cerebrovascular accident. [Срок оценки: 30 days after surgery]

Критерии участия

Критерии включения

Patients aged 18-65 years old, scheduled for elective abdominal surgery in general anesthesia with endotracheal intubation; ASA I-III grade; cardiac function 1-2 grade; 18 kg/m2 < BMI < 28 kg/m2; Preoperative SpO2 ≥ 94% without oxygen supplementation at rest; pre-anesthesia assessment shows no difficult airway, no difficulty with mask ventilation, no difficulty in intubation during tracheal insertion, and no difficulty in extubation as expected.

Критерии исключения

Respiratory infection recently, or atelectasis, inflammation, fibrosis, or pleural effusion by chest CT preoperatively.

History thoracic surgery and fractures of the sternum or ribs, chest deformity, difficulty in raising both upper limbs, or scoliosis.

High risk of reflux aspiration. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis).

Limb movement disorders. Mask ventilation or intubation difficulty during anesthesia induction. Occurrence of severe allergy, massive bleeding, suspected pulmonary embolism, pulmonary edema, myocardial injury, or cardiopulmonary arrest during surgery.

Currently participating in other clinical studies, which may have an impact on this study.

Inability to cooperate well for mental disorder, or hypophrenia.

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

Здоровые добровольцы: Нет