Lung Cancer, Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary, Segmentectomy
Conditions
Keywords
Lung segmentectomy, Intersegmental plane, Inflation-deflation method, Carbon dioxide
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURE100% 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.
PROCEDURECarbon 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.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years of age. 2. Segmentectomy is feasible according to the reconstructed 3-dimensional (3D) images. 3. Pulmonary nodule 2 cm or smaller in diameter with 50% or more ground-glass opacity (GGO) on thin-slice computed tomography, indicating an underlying malignancy. 4. Ability to provide written informed consent. 5. Unable to tolerate lobectomy as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation. 6. Diagnosis confirmed or suspected of lung metastatic cancer.
Exclusion criteria
1. Patients who are at risk for general anesthesia. 2. Patients with serious mental illness. 3. Pregnancy or lactating women. 4. Active bacterial or fungal infections. 5. Panties with Interstitial pneumonia, pulmonary fibrosis or severe emphysema. 6. Conversion to thoracotomy in surgery. 7. Preoperative assessment of patients undergoing lobectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Intersegmental Border Appearance Time During the Surgery. | The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Arterial Blood Gas Results During Perioperative Period. | 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. | Extracting arterial blood gas. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Postoperative Complications. | 4 weeks after surgery. | Record the complications. |
| The Length of Hospital Stays. | Up to 14 days. | Duration of hospitalization after surgery. |
| Quality of Recovery. | Up to 7 days. | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 18 |
| Total | 41 |
Baseline characteristics
| Characteristic | Group A: 100% Oxygen | Group B: Carbon Dioxide | Total |
|---|---|---|---|
| Age, Continuous | 51.00 years STANDARD_DEVIATION 13.19 | 51.17 years STANDARD_DEVIATION 12.48 | 51.07 years STANDARD_DEVIATION 12.72 |
| body mass index (BMI) | 22.6 kg/m^2 STANDARD_DEVIATION 2.9 | 23.8 kg/m^2 STANDARD_DEVIATION 3 | 23.1 kg/m^2 STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 18 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 23 participants | 18 participants | 41 participants |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 18 |
| other Total, other adverse events | 5 / 23 | 3 / 18 |
| serious Total, serious adverse events | 0 / 23 | 0 / 18 |
Outcome results
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.
Time frame: The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons during the surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: 100% Oxygen | The Intersegmental Border Appearance Time During the Surgery. | 748.74 seconds | Standard Deviation 177.16 |
| Group B: Carbon Dioxide | The Intersegmental Border Appearance Time During the Surgery. | 157.11 seconds | Standard Deviation 76.75 |
Secondary
The Arterial Blood Gas Results During Perioperative Period.
Extracting arterial blood gas.
Time frame: 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.
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.
Time frame: Up to 7 days.
Other Pre-specified
The Incidence of Postoperative Complications.
Record the complications.
Time frame: 4 weeks after surgery.
Other Pre-specified
The Length of Hospital Stays.
Duration of hospitalization after surgery.
Time frame: Up to 14 days.