Effects of Different Ventilation Modes on Intraoperative Lung Injury and Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- occurrence rate of Oxygenation index≤300mmHg
研究概览
简要总结
In 1967, the term "respirator lung" was coined to describe the diffuse alveolar infiltrates and hyaline membranes that were found on postmortem examination of patients who had undergone mechanical ventilation.This mechanical ventilation can aggravate damaged lungs and damage normal lungs. In recent years, Various ventilation strategies have been used to minimize lung injury, including low tide volume, higher PEEPs, recruitment maneuvers and high-frequency oscillatory ventilation. which have been proved to reduce the occurrence of lung injury.
In 2012,Needham et al. proposed a kind of lung protective mechanical ventilation, and their study showed that limited volume and pressure ventilation could significantly improve the 2-year survival rate of patients with acute lung injury.Volume controlled ventilation is the most commonly used method in clinical surgery at present.Volume controlled ventilation(VCV) is a time-cycled, volume targeted ventilation mode, ensures adequate gas exchange. Nevertheless, during VCV, airway pressure is not controlled.Pressure controlled ventilation（PCV） can ensure airway pressure,however minute ventilation is not guaranteed.Pressure controlled ventilation-volume guarantee(PCV-VG) is an innovative mode of ventilation utilizes a decelerating flow and constant pressure. Ventilator parameters are automatically changed with each patient breath to offer the target VT without increasing airway pressures. So PCV-VG has the advantages of both VCV and PCV to preserve the target minute ventilation whilst producing a low incidence of barotrauma pressure-targeted ventilation.
Current studies on PCV-VG mainly focus on thoracic surgery, bariatric surgery and urological surgery, and the research indicators mainly focus on changes in airway pressure and intraoperative oxygenation index.The age of patients undergoing laparoscopic colorectal cancer resection is generally higher, the cardiopulmonary reserve function is decreased, and the influence of intraoperative pneumoperitoneum pressure and low head position increases the incidence of intraoperative and postoperative pulmonary complications.Whether PCV-VG can reduce the incidence of intraoperative lung injury and postoperative pulmonary complications in elderly patients undergoing laparoscopic colorectal cancer resection, and thereby improve postoperative recovery of these patients is still unclear.
详细描述
One hundred patients undergoing elective laparoscopic colorectal cancer resection (age > 65 years old, body mass index(BMI）18-30 kg/m2, American society of anesthesiologists(ASA )grading Ⅰ - Ⅲ ) will be randomly assigned to volume control ventilation(VCV)group and pressure controlled ventilation-volume guarantee(PCV-VG)group.General anesthesia combined with epidural anesthesia will be used to both groups.
Ventilation settings in both groups are VT 8 mL/kg,inspiratory/expiratory (I/E) ratio 1:2,inspired oxygen concentration (FIO2) 0.5 with air,2.0 L/min of inspiratory fresh gas flow,positive end-expiratory pressure (PEEP) 0 millimeter of mercury （mmHg）,respiratory rate (RR) was adjusted to maintain an end tidal CO2 pressure (ETCO2) of 35 -45 mmHg.
In operation dates will be collected at the following time points: preanesthesia, 1 hour after pneumoperitoneum,2 hours after pneumoperitoneum ,30 minutes after admission to post-anaesthesia care unit (PACU) .The dates collected or calculated are the following:1)peak airway pressure,plate airway pressure, mean inspiratory pressure, dynamic compliance, RR,Exhaled VT andETCO2，2) Arterial blood gas analysis: arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2),power of hydrogen（PH）, and oxygen saturation (SaO2)，3) Oxygenation index (OI) calculation; PaO2/FIO2, 4) Ratio of physiologic dead-space over tidal volume(Vd/VT) (expressed in %) was calculated with Bohr's formula ; Vd/VT = (PaCO2 - ETCO2)/PaCO2,5) Hemodynamics: heart rate, mean arterial pressure (MAP),and central venous pressure （CVP），6) lung injury markers ：Interleukin 6(IL6）,Interleukin 8（IL8）,Clara cell protein 16（CC16）,Solution advanced glycation end products receptor（SRAGE）,tumor necrosis factor α(TNFα) .
Investigators will collect the following dates according to following-up after surgery: the incidence of postoperation pulmonary complications(PPC) based on PPC scale within seven days , incidence of pneumonia within seven days after surgery,incidence of atelectasis within seven days after surgery,length of hospital days after surgery, the incidence of postoperative unplanned admission to ICU, the incidence of operation complications within 7 days after surgery, the incidence of postoperative systematic complications within 7 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for Laparoscopic colorectal cancer resection
- •age >65 years
- •body mass index(BMI) 18-30kg / m2
- •ASA gradingⅠ-Ⅲ
排除标准
- •history of lung surgery
- •severe restrictive or obstructive pulmonary disease (preoperative lung function test: forced vital capacity(FVC)< 50% predictive value of FVC,forced expiratory volume at one second(FEV1)< 50% predictive value of FEV1
- •Acute respiratory failure, pulmonary infection, ALI/ARDS, and acute stage of asthmaAcute respiratory failure, pulmonary infection, acute lung injury(ALI),acute respiratory distress syndrome(ARDS), and acute stage of asthma (bronchodilators were needed for treatment) were found within 1 month before surgery
- •Patients at risk of preoperative reflux aspiration
- •Preoperative positive pressure ventilation (as obstructive sleep apnea hypopnea syndrome patients) or long-term home oxygen therapy were performed
- •Serious heart, liver and kidney diseases: heart function class more than 3, severe arrhythmia (sinus bradycardia (ventricular rate < 60 times/min), atrial fibrillation, atrial flutter, atrioventricular block, frequent premature ventricular and polyphyly ventricular early, early to R on T, ventricular fibrillation and ventricular flutter), acute coronary syndrome, liver failure, kidney failure
- •Neuromuscular diseases affect respiratory function, such as Parkinson's disease, myasthenia gravis and cerebral infarction affect normal breathing
- •Mental illness, speech impairment, hearing impairment
- •Contraindications for spinal anesthesia puncture
- •Refuse to participate in this study or participate in other studies -
研究组 & 干预措施
pressure-controlled ventilation-volume guaranteed
patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
干预措施: pressure-controlled ventilation-volume guaranteed (Procedure)
volume controlled ventilation
patients will be allocated to volume controlled ventilation in operation
干预措施: volume controlled ventilation (Procedure)
结局指标
主要结局
occurrence rate of Oxygenation index≤300mmHg
时间窗: 10minutes before anesthesia,1 hour after pneumoperitoneum,2 hour after pneumoperitoneum,30 minutes after after extubation
Oxygenation index(OI)=PaO2/FiO2
次要结局
- Plateau airway pressure(through mechanical ventilation,average of 3 hours)
- assessing change of Alveolar-arterial oxygen tension difference(10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation)
- incidence of pneumonia(Day 0 to 7 after surgery)
- peak airway pressure(through mechanical ventilation,average of 3 hours)
- assessing change of Respiratory index(10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation)
- assessing change of Alveolar dead space fraction(10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum,30 minutes after extubation)
- assessing change of Tumor Necrosis Factor alpha(10 minutes before anesthesia,30 minutes after extubation)
- Occurrence rate of operation complications(within 7 days after operation)
- incidence of pulmonary atelectasis(Day 0 to 7 after surgery)
- Dynamic lung compliance(through mechanical ventilation,average of 3 hours)
- assessing change of Interleukin 6(10 minutes before anesthesia,30 minutes after extubation)
- Antibiotic dosages(within 7 days after surgery)
- Length of ICU stay within 30 days after surgery(within 30 days after surgery)
- Occurrence rate of pulmonary complications(Day 0 to 7 after surgery)
- Arterial partial pressure of oxygen(10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation)
- assessing change of Advanced glycation end products receptor(10 minutes before anesthesia,30 minutes after extubation)
- assessing change of Interleukin 8(10 minutes before anesthesia,30 minutes after extubation)
- Occurrence rate of Systemic complications(within 7 days after surgery)
- Death from any cause(within 30 days after surgery)
- Static lung compliance(through mechanical ventilation,average of 3 hours)
- The occurrence rate of hypoxemia after surgery(within 7 days after surgery)
- assessing change of lactic acid(10 minutes before anesthesia, 1 hour after pneumoperitoneum, 2 hours after pneumoperitoneum, 30 minutes after extubation)
- assessing change of Clara cell protein 16,(10 minutes before anesthesia,30 minutes after extubation)
- The occurrence rate of hypoxemia in PACU(30 minutes after extubation)
- incidence of Unplanned admission to ICU(within 30 days after surgery)
- Length of hospital stay within 30 days after surgery(within 30 days after surgery)
研究者
Dongxue Li
Principal Investigator, The department of anesthesiology ,Sixth Affiliated Hospital, Sun Yat-sen University
Sixth Affiliated Hospital, Sun Yat-sen University