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Recruiting NCT06644066

Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial pressure of Oxygen Control method.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Time of Intersegmental plane（TISP） [Time frame: Throughout the entire surgical period，an average of 10 minutes]
  • The lung collapse score [Time frame: Throughout the entire surgical period]
Secondary outcome measures (7)
  • Surgical time [Time frame: Throughout the entire surgical period，An average of 120 minutes]
  • Blood gas analysis [Time frame: Throughout the entire surgical period，Baseline, Up to 120 minutes]
  • Intraoperative bleeding volume [Time frame: Throughout the entire surgical period]
  • Postoperative drainage volume [Time frame: Intraoperative]
  • Postoperative complication incidence [Time frame: Throughout the perioperative period，Baseline, Up to 3 months]
  • Postoperative hospitalization days [Time frame: From surgery to discharge ，An average of 5 days]
  • Total hospitalization cost [Time frame: Up to 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of the Air Force Medical University of PLA — Xi'an

Publications

  • 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

Identifiers

NCT: NCT06644066 · K202406-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗