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Набор скоро начнётся NCT07720778

ORI-Guided Oxygen Therapy During One-Lung Ventilation

Без фазы С лечением Thoracic Surgery With One-lung Ventilation

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: ORI-Guided FiO2 Titration, Conventional SpO₂-Guided FiO₂ Titration.
Кому может быть актуально
Состояния в реестре: Thoracic Surgery With One-lung Ventilation. Базовые параметры: от 19 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
South Korea
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 Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation

Обзор

High inspired oxygen concentrations (FiO₂) are commonly administered during general anesthesia to prevent hypoxemia. However, excessive oxygen administration may result in hyperoxemia, which has been associated with impaired hypoxic pulmonary vasoconstriction, increased oxidative stress, ventilation-perfusion mismatch, and postoperative pulmonary complications. During one-lung ventilation (OLV) for thoracic surgery, higher FiO₂ is often required because of increased intrapulmonary shunting, making hyperoxemia a frequent occurrence. The Oxygen Reserve Index (ORI) is a noninvasive pulse oximetry-derived parameter that reflects moderate hyperoxemia (PaO₂ approximately 100-200 mmHg) and may facilitate more precise oxygen titration than pulse oximetry alone.

Подробное описание

This prospective, randomized, assessor-blinded clinical trial aims to determine whether FiO₂ titration guided by both ORI and peripheral oxygen saturation (SpO₂) reduces the incidence of hyperoxemia compared with conventional SpO₂-guided FiO₂ titration during OLV in patients undergoing thoracic surgery. Participants will be randomly assigned to either an ORI-guided group or a conventional SpO₂-guided group. The primary outcome is the incidence of hyperoxemia (PaO₂ \>125 mmHg) after OLV. Secondary outcomes include SpO₂, ORI, PaO₂, and FiO₂ measured

Вмешательства

  • Другое ORI-Guided FiO2 Titration
    During one-lung ventilation, FiO₂ is adjusted according to both ORI and SpO₂. FiO₂ is titrated to maintain SpO₂ ≥98% while keeping ORI above 0 to minimize hyperoxemia.
  • Другое Conventional SpO₂-Guided FiO₂ Titration
    During one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone. FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care.

Первичные конечные точки

  • Incidence of hyperoxemia during one-lung ventilation [Срок оценки: 10 min after initiation of one-lung ventilation during operation]
Вторичные конечные точки (4)
  • Peripheral oxygen saturation (SpO₂) [Срок оценки: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
  • Oxygen Reserve Index (ORI) [Срок оценки: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
  • Arterial oxygen tension (PaO₂) [Срок оценки: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
  • Fraction of inspired oxygen (FiO₂) [Срок оценки: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]

Критерии участия

Критерии включения

  • Adults aged ≥19 years
  • Scheduled for elective lung surgery requiring one-lung ventilation
  • Written informed consent

Критерии исключения

  • Severe pulmonary hypertension.
  • Left ventricular systolic dysfunction.

Withdrawal Criteria:

  • The participant or legally authorized representative requests withdrawal from the study.
  • An adverse event occurs that precludes continued participation in the study.
  • The planned surgery or study procedures are not performed (e.g., ORI monitoring is not applied or arterial blood gas analysis is not performed).
  • Perfusion Index is less than 2 during the study.
  • A major violation of the inclusion or exclusion criteria is identified after enrollment.
  • The participant fails to comply with the study protocol, potentially affecting the validity of the study outcomes.
  • Continued participation is considered not to be in the participant's best interest.
  • In the investigator's judgment, any other condition arises that makes continued participation inappropriate.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Konkuk University Medical Center — Seoul

Идентификаторы

NCT: NCT07720778 · KUMC 2026-05-061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗