Application of Nitrous Oxide in Inflation-deflation Process During Thoracoscopic Segmentectomy
Study Details
Study Description
Brief Summary
Lung cancer is currently one of the most common malignant tumors in the world. In recent years, with the popularity of high-resolution CT, more and more early-stage lung cancers have been found. Anatomic pneumonectomy is gradually popular because it can completely remove lung nodules and preserve lung function to the greatest extent. During the surgery, the precise and rapid determination of intersegmental border is one of the key technologies. Improved inflation-deflation method is currently the most widely used method in clinical practice. Previous studies demonstrated that increasing the concentration of nitrous oxide in mixtures of N2O/O2 will lead to a faster rate of collapse. The rapid diffusion properties of N2O would be expected to speed lung collapse and so facilitate surgery. This study was designed to explore three types of inspired gas mixture used during two-lung anesthesia had an effect on the intersegmental border appearance time during pneumonectomy and its feasibility and safety: 75% N2O (O2: N2O = 1: 3), 50% N2O (O2: N2O = 1: 1), 100% oxygen.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The study protocol was approved by the Ethics Committee of The First Affiliated Hospital of Nanjing Medical University. This randomized parallel group trial enrolled lung cancer patients scheduled to receive thoracoscopic anatomic segmentectomy at The First Affiliated Hospital of Nanjing Medical University. The allocation sequence was generated using a computer program by a staff member not otherwise involved in the trial. Electrocardiogram (ECG), pulse oximetry (SpO2), heart rate (HR), blood pressure (BP), respiratory rate (RR), and end-expiratory carbon dioxide (PetCO2) were monitored routinely after admission. A superficial vein in the forearm was opened, and sodium lactate Ringer's solution was infused intravenously. Parallel radial arterial catheterization was performed to monitor invasive arterial blood pressure. All patients received pure oxygen ventilation for at least three minutes during the induction of anesthesia. Anesthesia induction was achieved with midazolam 0.1-0.4mg / kg, etomidate 0.2-0.4mg / kg, cisatracurium 0.15-0.2mg / kg, fentanyl 4-6ug / kg, dexamethasone10mg, double-lumen tracheal tube intubation under the laryngoscope, and adjustment of the position of the double-lumen tube under fiber bronchoscope, Give double lung ventilation with pure oxygen. After turning over to lateral position, adjust the position of the double lumen under the fiber bronchoscope again, clamp the non-ventilated end of the double lumen tracheal tube and connect the distal end with the atmosphere to perform single lung ventilation. Mechanical ventilation was performed with pure oxygen on the side. Anesthesia was maintained with continuous infusion of propofol 120-200μg/kg-1min-1 , cisatracurium 1-2μg/kg-1min-1 ,remifentanil 0.25-4μg/kg-1min-1 and dexmedetomidine0.2-0.7μg/kg-1h-1 as deemed necessary. Tidal volume was 6-8 mL/kg ideal bodyweight (male: height -100, and female: height - 105) without positive end expiratory pressure,and the breathing rate was set to 10-18 beats / min,PetCO2 is maintained at 30-40mmHg). After the surgeon has finely dissected the target artery, vein, and bronchi, accurately judged and processed it, the sputum suction operation was performed on the healthy and surgical lungs, and the patient with the end-of-breath carbon dioxide sampling tube on the monitor was terminated to a portable nitrous oxide concentration detector (TD600-SH-N2O)to measure the test gas concentration (express in vol%), by adjusting the adjustable pressure limit valve ( APL) of the anesthesia machine to 0 in advance to exhaust the residual gas in the airbag, change the anesthesia machine to manual control mode, adjust the oxygen flow rate and N2O flow rate of the ventilator (group A is 100% O2, group B is 75% N2O (set N2O: O2 = 3: 1 ), Group C is 50% N2O (set N2O: O2 = 1: 1)), adjust the APL valve to 20cmHg, so that the storage gas bag is filled with test gas, adjust the APL valve to 0 again, exhaust the residual gas, adjust the APL valve to 20, make the N2O concentration detector reach the predetermined gas concentration, and test the gas through the dual-lumen tracheal tube to positive pressure ventilation with high frequency and low tidal volume to expand the lungs, the pressure is limited to 20cmHg, after the lungs is completely expanded, performing pure oxygen mechanical single lung ventilation, waiting for clear presentation of the plane between segments .(The starting point of intraoperative expansion and collapse observation is the time when the lung tissue is completely expanded after blocking the relevant structure of the target segment; the end point is when a clear demarcation is formed between the target segment and the immediately-reserved lung segment, and this boundary does not follow significant changes over time).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: group A 100% O2 After the targeted segment bronchus, artery, and intrasegmental vein were identified and dissected by ligation or stapler cutting, the sputum suction operation was performed on the healthy and surgical lungs,by adjusting the APL valve (adjustable pressure limit valve) of the anesthesia machine to 0 in advance to exhaust the residual gas in the airbag, change the anesthesia machine to manual control mode, adjust the oxygen flow rate of the ventilator (group A is 100% O2 ), adjust the APL valve to 20cmHg, so that the storage gas bag is filled with test gas, and test the gas through the dual-lumen tracheal tube to positive pressure ventilation with high frequency and low tidal volume to expand the lungs, the pressure is limited to 20cmHg, after the lungs where the target segment is completely expanded, perform pure oxygen mechanical single lung ventilation, waiting for clear presentation of the plane between segments. |
Procedure: nitrous oxide
During one-lung ventilation with an open chest, the nonventilated lung collapses initially due to elastic recoil, which quickly brings the lung down to its closing capacity. Remaining gas in the lung is then removed by absorption into the pulmonary capillary blood. The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
Other Names:
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| Experimental: group B 75% N2O After the surgeon has finely dissected the target artery, vein, and bronchi, accurately judged and processed it,and the patient with the end-of-breath carbon dioxide sampling tube on the monitor was terminated to a portable TD600-SH-N2O detection end of the nitrous oxide concentration detector to measure the test gas concentration (express in vol%), by adjusting the APL valve (adjustable pressure limit valve) of the anesthesia machine to 0 in advance to exhaust the residual gas in the airbag, change the anesthesia machine to manual control mode, adjust the oxygen flow rate to 1 and N2O flow rate of the ventilator to 3( group B 75% N2O), adjust the APL valve to 20cmHg, making the N2O concentration detector reach the predetermined gas concentration, and test the gas through the dual-lumen tracheal tube to positive pressure ventilation with high frequency and low tidal volume to expand the lungs, the pressure is limited to 20cmHg. |
Procedure: nitrous oxide
During one-lung ventilation with an open chest, the nonventilated lung collapses initially due to elastic recoil, which quickly brings the lung down to its closing capacity. Remaining gas in the lung is then removed by absorption into the pulmonary capillary blood. The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
Other Names:
|
| Experimental: Group C 50% N2O After the surgeon has finely dissected the target artery, vein, and bronchi, accurately judged and processed it, and the patient with the end-of-breath carbon dioxide sampling tube on the monitor was terminated to a portable TD600-SH-N2O detection end of the nitrous oxide concentration detector to measure the test gas concentration (express in vol%), by adjusting the APL valve (adjustable pressure limit valve) of the anesthesia machine to 0 in advance to exhaust the residual gas in the airbag, change the anesthesia machine to manual control mode, adjust the oxygen flow rate to 1 and N2O flow rate of the ventilator to 1( group C 50% N2O), adjust the APL valve to 20cmHg, making the N2O concentration detector reach the predetermined gas concentration, and test the gas through the dual-lumen tracheal tube to positive pressure ventilation with high frequency and low tidal volume to expand the lungs, the pressure is limited to 20cmHg. |
Procedure: nitrous oxide
During one-lung ventilation with an open chest, the nonventilated lung collapses initially due to elastic recoil, which quickly brings the lung down to its closing capacity. Remaining gas in the lung is then removed by absorption into the pulmonary capillary blood. The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
Other Names:
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Outcome Measures
Primary Outcome Measures
- The intersegmental border appearance time during the surgery [The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons]
The starting point of intraoperative expansion and collapse observation is the time when the lung tissue is completely expanded after blocking the relevant structure of the target segment; the end point is when a clear demarcation is formed between the target segment and the immediately-reserved lung segment, and this boundary does not follow significant changes over time).
Secondary Outcome Measures
- The arterial blood gas results during perioperative period [Immediately after the radial arterial catheterization when inhaling the air, pre-intervention, 5minutes, 15minnutes during the single lung ventilation after the intervention]
Extracting arterial blood gas
Other Outcome Measures
- The incidence of postoperative complications and the length of hospital stay [2 weeks after surgery.]
Record the complications and the length of hospital stay
Eligibility Criteria
Criteria
Inclusion Criteria:
1、20 to 75 years of age;
2、American Society of Anesthesiologists (ASA) physical status I or II;
3、body mass index between 18 and 25 kg/m2；
4、lung cancer or pulmonary nodules patients schedule to receive thoracoscopic anatomic segmentectomy;
Exclusion Criteria:
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allergic to nitrous oxide；
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pneumothorax or using artificial pneumothorax,abnormal expiratory recoil [forced expiratory volume at 1 second (FEV1) < 70% of predicted value]；
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persons who with previous intestinal obstruction, flatulence or pneumonia；
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pleural adhesion anticipated during preoperative assessment, or bullae on chest computed tomography scans；
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a history of severe asthma, chronic obstructive pulmonary disease(COPD) or thoracic surgery, a risk of blood or infected secretions contaminating the dependent lung as well as expected difficult intubation；
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
| 2 | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
Investigators
- Study Chair: cunming liu, doctorate, The First Affiliated Hospital with Nanjing Medical University
- Study Director: quan zhu, doctorate, The First Affiliated Hospital with Nanjing Medical University
- Study Director: shijiang liu, Attending physician, The First Affiliated Hospital with Nanjing Medical University
- Principal Investigator: wenjing yang, master, The First Affiliated Hospital with Nanjing Medical University
- Principal Investigator: zicheng liu, master, The First Affiliated Hospital with Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-SR-449