Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Partial pressure of Oxygen Control method

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingliang Xing; Phone Number: 15129745755; Email: 312596733@QQ.COM
• Study Contact Backup: Name: Xiaolong Yan, MD; Phone Number: 15991269383; Email: yanxiaolong@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The Second Affiliated Hospital of the Air Force Medical University of PLA
      • Contact: Mingliang Xing; Phone Number: 15129745755; Email: 312596733@QQ.COM
      • Contact: Xiaolong Yan, MD; Phone Number: 15991269383; Email: yanxiaolong@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	The total time from the start of skin incision to the completion of chest closure	Throughout the entire surgical period，An average of 120 minutes
Blood gas analysis	Blood gas analysis measuring before entry, after one lung ventilation (SpO2 maintained at 95%), after pure oxygen lung stimulation, and at 3 and 6 minutes after pure oxygen lung expand.	Throughout the entire surgical period，Baseline, Up to 120 minutes
Intraoperative bleeding volume	Intraoperative bleeding volume: Use a suction device and a graduated collection device to collect intraoperative bleeding volume in milliliters, accurate to ten digits. (An average of 50ml)	Throughout the entire surgical period
Postoperative drainage volume	Postoperative drainage volume: The total drainage volume in the drainage bottle during the retention of the thoracic catheter after surgery, in milliliters. (An average of 200ml)	Intraoperative
Postoperative complication incidence	Postoperative complication incidence: Record the name of the complication and classify it according to the Clavien Indo classification system	Throughout the perioperative period，Baseline, Up to 3 months
Postoperative hospitalization days	The number of days between the surgical date and the discharge date;	From surgery to discharge ，An average of 5 days
Total hospitalization cost	Total hospitalization cost: The total cost of patients from admission to discharge, settled in ChiNaYuan（CNY） (before medical insurance settlement).	Up to 3 months

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): July 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Intersegmental plane; Sublobar resection; Non small cell lung cancer(NSCLC); Partial pressure of Oxygen Control method; Video-assisted thoracoscopic(VATS)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: K202406-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No