Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane

Tang-Du Hospital

Status: Enrolling

Conditions: Lung Cancer

Treatments: Procedure: Partial pressure of Oxygen Control method

Study type: Interventional

Funder types: Other

Identifiers

NCT06644066

K202406-24

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Partial pressure of Oxygen Control method

Experimental group

Description:

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.

Treatment:

Procedure: Partial pressure of Oxygen Control method

Modified inflation-deflation method

No Intervention group

Description:

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.