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Идёт набор NCT06359106

Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia

Фаза IV С лечением Oxygenation Index

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: 80% Oxygen, 40% Oxygen.
Кому может быть актуально
Состояния в реестре: Oxygenation Index. Базовые параметры: от 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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Обзор

This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.

Подробное описание

This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged \> 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.

Вмешательства

  • Препарат 80% Oxygen
    After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.
  • Препарат 40% Oxygen
    After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.

Первичные конечные точки

  • Oxygenation Index [Срок оценки: On the postoperative 48th hour]
Вторичные конечные точки (8)
  • pH value in blood gas analysis 48 hours after the operation [Срок оценки: On the postoperative 48th hour]
  • oxygen inhalation time [Срок оценки: On the postoperative 48 hour]
  • inspired oxygen concentration [Срок оценки: On the postoperative 48 hour]
  • oxygen uptake rate [Срок оценки: On the postoperative 48 hour]
  • 7 days pulmonary complications [Срок оценки: On the postoperative 7th day]
  • 30-day Mortality [Срок оценки: On the postoperative 30th day]
  • PaCO2 in blood gas analysis 48 hours after the operation [Срок оценки: On the postoperative 48th hour]
  • Lactic acid in blood gas analysis 48 hours after the operation [Срок оценки: On the postoperative 48th hour]

Критерии участия

Критерии включения

  • Age not less than 65 years
  • American Society of Anesthesiologists grades I-III
  • No history of drug allergies or abnormal anesthesia.
  • The duration of mechanical ventilation was expected to be more than 2 hours.
  • Laparoscopic Gastrointestinal Surgery
  • The preoperative oxygen saturation was not less than 94%.
  • The patients will be planned to extubate in the operating room.

Критерии исключения

  • History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
  • Cardiac function Class IV (New York Heart Association classification)
  • Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
  • Patients with blurred consciousness and cognitive dysfunction
  • Severe coagulation dysfunction.
  • Without preoperative oxygen inhalation, blood oxygen level <94%, and severe pulmonary dysfunction
  • Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.
  • Body mass index (BMI) >30kg/m2
  • Inability to complete the study

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 16 центров
  • the First Hospital of China Medical University — Шэньян
  • Beijing Friendship Hospital, Capital Medical University — Пекин
  • Sichuan Provincial People's Hospital — Chendu
  • Chifeng Municipal Hospital — Chifeng
  • Dalian Third People's Hospital — Dalian
  • First Affiliated Hospital, Dalian Medical University — Dalian
  • First Affiliated Hospital of Harbin Medical University — Харбин
  • Harbin Medical University Cancer Hospital — Харбин
  • … и ещё 8 центров

Публикации

  • Zhang T, An Y, Zhao S, Han F, Huang L, Wang L, Wu J, Lei Q, Wang K, Shao J, Wang Y, Luan Y, Feng W, Song J, Huang Z, Wu C, Nan Y, Tang B, Sun X, Tan W. Effects of varying inhaled oxygen concentrations on lung function in older adult patients undergoing laparoscopic gastrointestinal surgery under general anesthesia: protocol of a prospective multicenter clinical study in China. Trials. 2026 Jan 23; PMID 41572351

Идентификаторы

NCT: NCT06359106 · 2024.3.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗