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Trial Title:
Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane
NCT ID:
NCT06644066
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Sublobar resection
Intersegmental plane
Non small cell lung cancer(NSCLC)
Partial pressure of Oxygen Control method
Video-assisted thoracoscopic(VATS)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Partial pressure of Oxygen Control method
Description:
During the process of inflation-deflation, by maintaining a lower PaO2, the identifying
the intersegmental plane is accelerated
Arm group label:
Partial pressure of Oxygen Control method
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of the Air Force Medical University of PLA
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolong Yan, MD
Phone:
15991269383
Email:
yanxiaolong@fmmu.edu.cn
Contact backup:
Last name:
Mingliang Xing
Phone:
15129745755
Email:
312596733@QQ.COM
Start date:
May 1, 2024
Completion date:
October 30, 2024
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644066
