NCT06644066Recruiting
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
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Jul 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06644066
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 May 2024 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who undergo chest surgery due to various reasons or change the surgical plan during the operation;
Other illness
- Individuals with a history of lung surgery in the past;
Other
- Patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema;
- The subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.
Who the study is looking for
- Between the ages of 18 and 75;
- Gender unlimited;
- Eastern Cooperative Oncology Group（ECOG） Performance status（PS） score 0-1 points;
- Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm and 0 ≤ CTR\<1.0; （Consolidation Tumor Ratio，CTR）
- Those who voluntarily sign the informed consent form for research can comply with the requirements of the research visit plan and other protocols.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of the Air Force Medical University of PLA Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.