The Effect of Alveolar Recruitment on Perioperative Outcomes in Obese Patients in Major Gynaecological Cancer Surgery: a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative pulmonary complications
研究概览
简要总结
In this study, the investigators planned to evaluate the effect of alveolar recruitment strategy primarily on postoperative pulmonary complications in obese patients undergoing lung protective ventilation in major open gynaeco-oncological surgeries. Our other aim was to evaluate perioperative haemodynamics, respiratory mechanics,inpatient length of stay.
详细描述
In the gynaecological oncology clinic of our hospital, open major surgeries for endometrial or ovarian cancer are performed very frequently. In these surgeries, the abdomen is open to the operating theatre environment and the lithotomy and trendelenburg position may have negative consequences on the respiratory system in patients. Intraoperative lung protective ventilation strategies are recommended to reduce postoperative pulmonary complications. In the lung protective ventilation strategy, positive end-expiratory pressure is recommended in addition to 6-8 ml/kg tidal volume according to ideal body weight. In addition, alveolar recruitment strategy can be applied. For this purpose, the investigators planned to evaluate the effect of alveolar recruitment strategy on postoperative pulmonary complications in patients who underwent lung protective ventilation in major open gynaecooncological surgeries. Our secondary aim was to evaluate perioperative haemodynamics, respiratory mechanics, inpatient length of stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with ASAII and III
- •BMI>30 kg/m2 ,<40 kg/m2
- •Patients with an ARISCAT risk score of 26-44
排除标准
- •Patients with an Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score > 44
- •BMI > 40 kg/m2 patients
研究组 & 干预措施
Group 1, lung protective ventilation with alveolar recruitment
In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.
干预措施: alveolar recruitment strategy applied group (Device)
Group 1, lung protective ventilation with alveolar recruitment
In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.
干预措施: group without alveolar recruitment strategy (Drug)
Group 2, lung protective ventilation without alveolar recruitment
In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.
干预措施: alveolar recruitment strategy applied group (Device)
Group 2, lung protective ventilation without alveolar recruitment
In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.
干预措施: group without alveolar recruitment strategy (Drug)
结局指标
主要结局
postoperative pulmonary complications
时间窗: 24 hours postoperatively
Our primary aim was to compare the presence of postoperative pulmonary complications. The presence of these pulmonary complications will be compared between preoperative chest X-ray and postoperative day 1 X-ray imaging in patients with Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score below 44.
次要结局
- intraoperative haemodynamic parameters(intraoperatively)
研究者
Duygu Akyol
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital