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Набор скоро начнётся NCT07381517

Correlation of Oxygenation and Saturation Indices in One-Lung Ventilation

Наблюдательное One-lung Ventilation (OLV)

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: One-lung Ventilation (OLV). Базовые параметры: от 18 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Correlation Between Oxygenation Indices (OI and Their Derivatives) and Oxygen Saturation Indices (OSI and Their Derivatives) During One-Lung Ventilation in Thoracic Surgery

Обзор

One-lung ventilation is commonly used during thoracic surgery but is frequently associated with impaired oxygenation and altered respiratory mechanics. Traditional oxygenation indices require arterial blood gas analysis and do not fully reflect the mechanical stress applied to the lungs. This prospective observational study aims to evaluate the correlation between oxygenation indices and oxygen saturation indices during one-lung ventilation in adult patients undergoing elective thoracic surgery. Modified indices incorporating driving pressure and mechanical power will also be assessed. No intervention beyond standard clinical care will be applied. The findings of this study may help clarify the clinical utility of non-invasive oxygenation indices for intraoperative monitoring during one-lung ventilation.

Подробное описание

One-lung ventilation induces complex changes in pulmonary physiology, including increased intrapulmonary shunt and altered respiratory mechanics, which may challenge conventional approaches to intraoperative oxygenation assessment. While invasive oxygenation indices are widely used, their applicability during one-lung ventilation is limited by the need for arterial blood gas sampling and the lack of integration of mechanical ventilation-related stress.

Non-invasive oxygen saturation-based indices have been proposed as alternatives; however, data regarding their performance under the dynamic physiological conditions of one-lung ventilation remain scarce. Furthermore, emerging concepts in lung-protective ventilation emphasize the importance of driving pressure and mechanical power as determinants of ventilator-induced lung injury, yet these parameters are not incorporated into traditional oxygenation metrics.

In this prospective observational study, invasive and non-invasive oxygenation indices, including modified forms incorporating driving pressure and mechanical power, will be recorded simultaneously during one-lung ventilation in adult patients undergoing elective thoracic surgery. The relationships and agreement between these indices will be analyzed to assess their comparability across different levels of mechanical respiratory load.

No intervention beyond standard clinical care will be applied. Ventilatory settings and perioperative management will be determined solely by routine clinical practice. This study is designed to provide methodological insight into the intraoperative applicability of non-invasive oxygenation indices during one-lung ventilation.

Первичные конечные точки

  • Correlation between oxygenation indices and oxygen saturation indices [Срок оценки: During intraoperative one-lung ventilation]

Критерии участия

Критерии включения

  • Patients aged 18 years and older
  • Patients classified as ASA physical status I-III
  • Patients scheduled for elective thoracic surgery requiring one-lung ventilation for at least 1 hour intraoperatively
  • Patients in whom simultaneous arterial blood gas analysis and continuous SpO₂ monitoring can be performed
  • Patients who have provided written informed consent

Критерии исключения

  • Patients undergoing emergency surgery
  • Patients younger than 18 years of age
  • Patients classified as ASA physical status IV or higher
  • Patients with a history of previous thoracic surgery
  • Patients with a body mass index (BMI) >40 kg/m² or <18 kg/m²
  • Patients with advanced chronic lung disease (COPD stage III-IV)
  • Patients with New York Heart Association (NYHA) class III-IV heart failure
  • Patients undergoing surgery due to pleural effusion

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Ataturk Sanatoryum Education and Research Hospital — Ankara

Публикации

  • Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5. PMID 38179691
  • Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1. PMID 18451319
  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. PMID 25693014

Идентификаторы

NCT: NCT07381517 · OLV-OXY-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗