Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

NCT06644066 | Recruiting

• 1 other identifier: K202406-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Sublobar resection; Intersegmental plane; Non small cell lung cancer(NSCLC); Partial pressure of Oxygen Control method; Video-assisted thoracoscopic(VATS)

Outcome Measures

Primary Outcomes (2)

• Time of Intersegmental plane（TISP）

  The start time was defined as the end of the surgical side lung having completely re-expanded. The end point was identified as the point at which the preserved lung was fully deflated, and a boundary had formed between the targeted lung tissue and the reserved lung.

  Throughout the entire surgical period，an average of 10 minutes

• The lung collapse score

  The lung collapse score was referenced and improved by the Bussiers method using descriptive and visual features that included the context of lung collapse, space in the thermal cavity, atelectasis, color of the lung (healthy lungs are a pink gray/simple color), and where the collapse was considered satisfactory.Lung collapse was defined on a 4-point scale, where 1 point int=no lung collapse, 2 point=less partial lung collapse, 3 point=major partial lung collapse, 4 point=total lung collapse Each video clip was assessed by 2 evaluators。 Independently evaluate the level, and resolve differences through consensus through negotiation.

  Throughout the entire surgical period

Secondary Outcomes (7)

• Surgical time

  Throughout the entire surgical period，An average of 120 minutes

• Blood gas analysis

  Throughout the entire surgical period，Baseline, Up to 120 minutes

• Intraoperative bleeding volume

  Throughout the entire surgical period

• Postoperative drainage volume

  Intraoperative

• Postoperative complication incidence

  Throughout the perioperative period，Baseline, Up to 3 months

Study Arms (2)

Partial pressure of Oxygen Control method

EXPERIMENTAL

After the targeted structures were successfully dissected, the anesthesiologist manually controls pure oxygen one-lung ventilation on the surgical side until the lung is fully expand. The ventilator is disconnected, the airway is opened, and the operator uses a gauze ball to pressure the preserve lung tissue. At a SpO2 of 95%, the healthy side undergoes one-lung ventilation.

Procedure: Partial pressure of Oxygen Control method

Modified inflation-deflation method

NO INTERVENTION

After the targeted structures were successfully dissected, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O, with the bronchus of the operation side open to atmosphere while continuing ventilation of the contralateral lung.

Interventions

Partial pressure of Oxygen Control method PROCEDURE

During the process of inflation-deflation, by maintaining a lower PaO2, the identifying the intersegmental plane is accelerated

Partial pressure of Oxygen Control method

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

The Second Affiliated Hospital of the Air Force Medical University of PLA

Xi'an, Shaanxi, 710000, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Xiaolong Yan, MD

CONTACT

15991269383; yanxiaolong@fmmu.edu.cn

Mingliang Xing

CONTACT

15129745755; 312596733@QQ.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: October 16, 2024
• Study Start: May 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)