Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

Not Applicable

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06644066
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-07-01
• Primary Completion: 2024-07-30
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time of Intersegmental plane（TISP）	Throughout the entire surgical period，an average of 10 minutes	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.
The lung collapse score	Throughout the entire surgical period	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.

Secondary Outcome Measures

Name	Time	Method
Surgical time	Throughout the entire surgical period，An average of 120 minutes	The total time from the start of skin incision to the completion of chest closure
Blood gas analysis	Throughout the entire surgical period，Baseline, Up to 120 minutes	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.
Intraoperative bleeding volume	Throughout the entire surgical period	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)
Postoperative drainage volume	Intraoperative	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)
Postoperative complication incidence	Throughout the perioperative period，Baseline, Up to 3 months	Postoperative complication incidence: Record the name of the complication and classify it according to the Clavien Indo classification system
Postoperative hospitalization days	From surgery to discharge ，An average of 5 days	The number of days between the surgical date and the discharge date;
Total hospitalization cost	Up to 3 months	Total hospitalization cost: The total cost of patients from admission to discharge, settled in ChiNaYuan（CNY） (before medical insurance settlement).

Trial Locations

Locations (1)

The Second Affiliated Hospital of the Air Force Medical University of PLA; 🇨🇳 Xi'an, Shaanxi, China