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With the increasing acceptance of routine computed tomography (CT) screenings, early-stage lung cancer detection is becoming more frequent. For ground glass opacity predominant early-stage lung cancer, segmentectomy can get the same oncological benefits as lobectomy. In addition, lung nodules that are highly suspected to be metastases can also be performed by segmentectomy to preserve more lung function. During the surgery, the rapid and precise identification of the intersegmental plane is one of the challenges. The improved inflation-deflation method is currently the most widely used method in clinical practice. According to the dispersion coefficient of the gas, the rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy.
This study was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. This randomized parallel group trial enrolled patients scheduled to receive thoracoscopic anatomic segmentectomy at Tongji Hospital. General anesthesia with double lumen endotracheal tube was administered to the patients. With the guidance of preoperative three-dimensional computed tomography bronchography and angiography, the targeted segment structures could be precisely dissected, and then intersegmental demarcation was confirmed by the modified inflation-deflation method in this study. In group A (100% oxygen), after dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. In group B (Carbon dioxide), after the targeted segment structures were successfully dissected, the collapsed operative lung was completely re-expanded with carbon dioxide. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy. The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 100% oxygen | Active Comparator | After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. |
|
| Group B: Carbon dioxide | Experimental | After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100% oxygen | Procedure | During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
| Measure | Description | Time Frame |
|---|---|---|
| The Intersegmental Border Appearance Time During the Surgery. | The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung. | The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons during the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The Arterial Blood Gas Results During Perioperative Period. | Extracting arterial blood gas. | Immediately after the radial arterial catheterization when inhaling the air, pre-intervention, 3-minutes, 5-minutes, 15-minutes during the single lung ventilation after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Postoperative Complications. | Record the complications. | 4 weeks after surgery. |
| The Length of Hospital Stays. | Duration of hospitalization after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital | Wuhan | Hubei | 430030 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 100% Oxygen | After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 100% oxygen: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
| FG001 | Group B: Carbon Dioxide | After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 100% Oxygen | After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 100% oxygen: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Intersegmental Border Appearance Time During the Surgery. | The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung. | Posted | Mean | Standard Deviation | seconds | The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons during the surgery. |
|
4 weeks after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: 100% Oxygen | After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 100% oxygen: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air leakage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wei Ping | Tongji Hospital affiliated Tongji Medical College of Huazhong University of Science and Technology | +8613437101581 | 247046170@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2023 | Jun 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003074 | Solitary Pulmonary Nodule |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D002245 | Carbon Dioxide |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D017554 |
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|
| Carbon dioxide | Procedure | During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
|
| Up to 14 days. |
| Quality of Recovery. | Measured using the Quality of Recovery 40 (QoR-40) Score and asking patients to complete the questions 24 hours before operation, 48 hours after operation and 1 week after operation. | Up to 7 days. |
| BG001 | Group B: Carbon Dioxide | After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Group B: Carbon Dioxide | After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. |
|
|
| Secondary | The Arterial Blood Gas Results During Perioperative Period. | Extracting arterial blood gas. | Not Posted | Immediately after the radial arterial catheterization when inhaling the air, pre-intervention, 3-minutes, 5-minutes, 15-minutes during the single lung ventilation after the intervention. | Participants |
| Other Pre-specified | The Incidence of Postoperative Complications. | Record the complications. | Not Posted | 4 weeks after surgery. | Participants |
| Other Pre-specified | The Length of Hospital Stays. | Duration of hospitalization after surgery. | Not Posted | Up to 14 days. | Participants |
| Other Pre-specified | Quality of Recovery. | Measured using the Quality of Recovery 40 (QoR-40) Score and asking patients to complete the questions 24 hours before operation, 48 hours after operation and 1 week after operation. | Not Posted | Up to 7 days. | Participants |
| 0 |
| 23 |
| 0 |
| 23 |
| 5 |
| 23 |
| EG001 | Group B: Carbon Dioxide | After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments. | 0 | 18 | 0 | 18 | 3 | 18 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Carbon Compounds, Inorganic |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |