Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

Официальное название

Application of Partial Pressure of Oxygen Control Method in Fast Identification of Intersegmental Plane in Anatomical Sublobar Resection: a Prospective, Randomized Controlled Study

Обзор

In recent years, an increasing number of pulmonary nodules have been detected through CT screening. The traditional surgical method for lung cancer is lobectomy combined with lymph node dissection. However, recent studies have demonstrated that sublobar resection for early non-small cell lung cancer (NSCLC) is an effective alternative with the additional benefit of preserving more pulmonary function. However, it also faces many problems, the most prominent of which is the rapid and accurate identification of the intersegmental plane (ISP) during surgery. The modified inflation-deflation method for identifying the ISP is the most commonly used method in anatomical sublobar resection. Nevertheless, the lengthy waiting periods and the lack of clear delineation represent significant challenges in clinical practice. The Partial pressure of Oxygen Control method facilitates the efficient determination of the ISP by reducing the oxygen inhalation concentration and ventilator ventilation time during surgery. This results in a reduced PaO2 in arterial blood, thereby accelerating the rapid appearance of the ISP. Thus, the investigators conducted a prospective, randomized, controlled trial to ascertain whether the oxygen partial pressure control method affects the occurrence time of the ISP and PaO2 during one-lung ventilation, in comparison to the modified inflation-deflation method. Furthermore, the objective was to confirm the safety and efficacy of Partial pressure of Oxygen Control method.

Вмешательства

• Процедура Partial pressure of Oxygen Control method
  During the process of inflation-deflation, by maintaining a lower PaO2, the identifying the intersegmental plane is accelerated

Первичные конечные точки

• Time of Intersegmental plane（TISP） [Срок оценки: Throughout the entire surgical period，an average of 10 minutes]
• The lung collapse score [Срок оценки: Throughout the entire surgical period]

Вторичные конечные точки (7)

• Surgical time [Срок оценки: Throughout the entire surgical period，An average of 120 minutes]
• Blood gas analysis [Срок оценки: Throughout the entire surgical period，Baseline, Up to 120 minutes]
• Intraoperative bleeding volume [Срок оценки: Throughout the entire surgical period]
• Postoperative drainage volume [Срок оценки: Intraoperative]
• Postoperative complication incidence [Срок оценки: Throughout the perioperative period，Baseline, Up to 3 months]
• Postoperative hospitalization days [Срок оценки: From surgery to discharge ，An average of 5 days]
• Total hospitalization cost [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

• Between the ages of 18 and 75;
• Gender unlimited;
• Eastern Cooperative Oncology Group（ECOG） Performance status（PS） score 0-1 points;
• Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm and 0 ≤ CTR<1.0; （Consolidation Tumor Ratio，CTR）
• Those who voluntarily sign the informed consent form for research can comply with the requirements of the research visit plan and other protocols.

Критерии исключения

• Individuals with a history of lung surgery in the past;
• Patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema;
• Those who undergo chest surgery due to various reasons or change the surgical plan during the operation;
• The subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of the Air Force Medical University of PLA — Сиань

Публикации

• Xing M, Tong L, Duan H, Aliev D, Dong X, Zhang Y, Liu H, Yan X. Partial pressure of oxygen control versus modified inflation-deflation method in identifying intersegmental plane during anatomical sublobectomy: a prospective, randomized, controlled trial. J Thorac Dis. 2025 Feb 28;17(2):1042-1053. doi: 10.21037/jtd-2025-45. Epub 2025 Feb 27. PMID 40083504

Идентификаторы

NCT: NCT06644066 · K202406-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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