Lung CancerNCT06644066
Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane
A study of Lung Cancer, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a history of lung surgery in the past;
- Patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema;
- Those who undergo chest surgery due to various reasons or change the surgical plan during the operation;
- The subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of the Air Force Medical University of PLA
Xi'an, Shaanxi, 710000
Xiaolong Yan, MD, 15991269383, yanxiaolong@fmmu.edu.cn
Mingliang Xing, 15129745755, 312596733@QQ.COM
About this study
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
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.
- Conditions
- Lung Cancer
- Being tested
- Partial pressure of Oxygen Control method
- Keywords
- Sublobar resection, Intersegmental plane, Non small cell lung cancer(NSCLC), Partial pressure of Oxygen Control method, Video-assisted thoracoscopic(VATS)
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial pressure of Oxygen Control methodProcedure or surgery
During the process of inflation-deflation, by maintaining a lower PaO2, the identifying the intersegmental plane is accelerated
| Study group | Role | What they receive |
|---|---|---|
| Partial pressure of Oxygen Control method | Experimental | 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. Receives: Procedure: Partial pressure of Oxygen Control method |
| Modified inflation-deflation method | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Intersegmental plane（TISP）
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.
Measured: Throughout the entire surgical period，an average of 10 minutes
The lung collapse score
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.
Measured: Throughout the entire surgical period
Secondary outcomes (7)
Surgical time
The total time from the start of skin incision to the completion of chest closure
Measured: Throughout the entire surgical period，An average of 120 minutes
Blood gas analysis
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.
Measured: Throughout the entire surgical period，Baseline, Up to 120 minutes
Intraoperative bleeding volume
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)
Measured: Throughout the entire surgical period
Postoperative drainage volume
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)
Measured: Intraoperative
Postoperative complication incidence
Postoperative complication incidence: Record the name of the complication and classify it according to the Clavien Indo classification system
Measured: Throughout the perioperative period，Baseline, Up to 3 months
Postoperative hospitalization days
The number of days between the surgical date and the discharge date;
Measured: From surgery to discharge ，An average of 5 days
Total hospitalization cost
Total hospitalization cost: The total cost of patients from admission to discharge, settled in ChiNaYuan（CNY） (before medical insurance settlement).
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 May 2024
- Primary completion30 Jul 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644066
- Sponsor's protocol ID
- K202406-24
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xing M, Tong L, Duan H, Aliev D, Dong X, Zhang Y, Liu H, Yan X. Partial pressure of oxygen control versus modified inflation-deflation method in identifying intersegmental plane during anatomical sublobectomy: a prospective, randomized, controlled trial. J Thorac Dis. 2025 Feb 28;17(2):1042-1053. doi: 10.21037/jtd-2025-45. Epub 2025 Feb 27.
PubMed 40083504
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06644066
- Acronym / sponsor ID
- K202406-24
- Conditions
- Lung Cancer
- Keywords
- Sublobar resection, Intersegmental plane, Non small cell lung cancer(NSCLC), Partial pressure of Oxygen Control method, Video-assisted thoracoscopic(VATS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial pressure of Oxygen Control method | Experimental | Procedure: Partial pressure of Oxygen Control methodAfter 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. |
| Modified inflation-deflation method | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Individuals with a history of lung surgery in the past;
- Patients with interstitial pneumonia, pulmonary alveoli, pulmonary fibrosis, or severe emphysema;
- Those who undergo chest surgery due to various reasons or change the surgical plan during the operation;
- The subjects do not understand, cooperate or refuse to sign the informed consent form regarding the research protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial pressure of Oxygen Control methodDuring the process of inflation-deflation, by maintaining a lower PaO2, the identifying the intersegmental plane is accelerated | Procedure or surgery | Partial pressure of Oxygen Control method |
Primary outcome
Time of Intersegmental plane（TISP）
Time frame: 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
Time frame: 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.
7 secondary outcomes
Surgical time
Time frame: Throughout the entire surgical period，An average of 120 minutes
Blood gas analysis
Time frame: Throughout the entire surgical period，Baseline, Up to 120 minutes
Intraoperative bleeding volume
Time frame: Throughout the entire surgical period
Postoperative drainage volume
Time frame: Intraoperative
Postoperative complication incidence
Time frame: Throughout the perioperative period，Baseline, Up to 3 months
Postoperative hospitalization days
Time frame: From surgery to discharge ，An average of 5 days
Total hospitalization cost
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 40083504Xing M, Tong L, Duan H, Aliev D, Dong X, Zhang Y, Liu H, Yan X. Partial pressure of oxygen control versus modified inflation-deflation method in identifying intersegmental plane during anatomical sublobectomy: a prospective, randomized, controlled trial. J Thorac Dis. 2025 Feb 28;17(2):1042-1053. doi: 10.21037/jtd-2025-45. Epub 2025 Feb 27.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lung Cancer, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Yan, MD (15991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Intersegmental plane（TISP） (time frame: Throughout the entire surgical period，an average of 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.