Clinical trial NCT06644066: Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane
Official title: Application of Partial Pressure of Oxygen Control Method in Fast Identification of Intersegmental Plane in Anatomical Sublobar Resection: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Sublobar resection
Intersegmental plane
Non small cell lung cancer(NSCLC)
Partial pressure of Oxygen Control method
Video-assisted thoracoscopic(VATS)
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time of Intersegmental plane（TISP）
timeFrame: Throughout the entire surgical period，an average of 10 minutes
measure: The lung collapse score
timeFrame: Throughout the entire surgical period
Secondary outcomes:
measure: Surgical time
timeFrame: Throughout the entire surgical period，An average of 120 minutes
measure: Blood gas analysis
timeFrame: Throughout the entire surgical period，Baseline, Up to 120 minutes
measure: Intraoperative bleeding volume
timeFrame: Throughout the entire surgical period
measure: Postoperative drainage volume
timeFrame: Intraoperative
measure: Postoperative complication incidence
timeFrame: Throughout the perioperative period，Baseline, Up to 3 months
measure: Postoperative hospitalization days
timeFrame: From surgery to discharge ，An average of 5 days
measure: Total hospitalization cost
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of the Air Force Medical University of PLA
state: Shaanxi
Study officials:
References: