Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

NCT ID: NCT06644066

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial pressure of Oxygen Control method

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.

Group Type: EXPERIMENTAL

Partial pressure of Oxygen Control method

Intervention Type: PROCEDURE

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

Modified inflation-deflation method

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Partial pressure of Oxygen Control method

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 18 and 75;

2. Gender unlimited;

3. Eastern Cooperative Oncology Group（ECOG） Performance status（PS） score 0-1 points;

4. Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm and 0 ≤ CTR<1.0; （Consolidation Tumor Ratio，CTR）

5. 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

1. Individuals with a history of lung surgery in the past;

2. Patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema;

3. Those who undergo chest surgery due to various reasons or change the surgical plan during the operation;

4. The subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaolong Yan, MD

Role: CONTACT

yanxiaolong@fmmu.edu.cn

15991269383

Mingliang Xing

Role: CONTACT

312596733@QQ.COM

15129745755

Facility Contacts

Xiaolong Yan, MD

Role: primary

yanxiaolong@fmmu.edu.cn

15991269383

Mingliang Xing

Role: backup

312596733@QQ.COM

15129745755

References

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.

Reference Type: DERIVED

PMID: 40083504 (View on PubMed)

Other Identifiers

K202406-24

Identifier Type: -

Identifier Source: org_study_id