Effects of Mechanical Ventilation Guided by Transpulmonary Pressure on Gas Exchange During Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Oxygenation Changes
研究概览
简要总结
Laparoscopy and robotic techniques are widespread procedures for pelvic gynecologic, urologic and abdominal surgery often performed in Trendelenburg position, with the application of pneumoperitoneum by inflating carbon dioxide. The rise in abdominal pressure following pneumoperitoneum and the head down body position have been shown to impair the respiratory function during the procedure, mainly inducing atelectasis formation in the dependent lung regions, worsening stress and strain of the alveolar structure.
The application of a ventilator strategy providing positive end-expiratory pressure (PEEP) has been shown to reduce the diaphragm cranial shift, increasing functional residual capacity and decreasing respiratory system elastance. Furthermore, the application of recruiting maneuver followed by the subsequent application of PEEP improved oxygenation. These results are in accordance with finding by Talmor et al, evaluating the effect of a mechanical ventilation guided by esophageal pressure in acute lung injury patients.
However a comparison between an esophageal pressure piloted mechanical ventilation and a conventional low tidal ventilator strategy with adjunct of PEEP and recruitment maneuvers according to clinical judgment has never been investigated in patients undergoing robotic gynecologic, abdominal or urologic surgery. The investigators aim to compare the conventional ventilation strategy (i.e. with application of PEEP and recruitment manoeuvre) with a ventilation driven by transpulmonary pressure assessed through an esophageal catheter, in patients undergoing to robotic surgery, with respect to oxygenation, expressed in terms of arterial oxygen tension - inspired oxygen fraction ratio (PaO2/FiO2) (primary endpoint), intraoperative respiratory mechanics indexes, number of lung recruitment maneuvers, rate and type of perioperative complications until hospital discharge (additional endpoint).
详细描述
INTRODUCTION Laparoscopy and robotic techniques are widespread procedures for pelvic gynecologic, urologic and abdominal surgery often performed in Trendelenburg position. Furthermore, in order to ameliorate surgical procedures, pneumoperitoneum is applied by inflating carbon dioxide. However, the rise in abdominal pressure following pneumoperitoneum and the head down body position have been shown to impair the respiratory function during the procedure, mainly inducing atelectasis formation in the declive lung regions. Consequently, functional residual capacity decreases and the risk of perioperative complications, such as hypoxaemia, rises up, particularly if patients are obese. Formation of atelectasis may worsen stress and strain of the alveolar structure. Stress, strain and atelectrauma give rise to ventilator-induced lung injury.
Although the role of ventilator-induced lung injury during general anesthesia is unclear, several investigations have been conducted with the purpose of improving arterial oxygenation and respiratory mechanics during laparoscopy. A ventilator strategy providing positive end-expiratory pressure (PEEP) has been shown to reduce the diaphragm cranial shift, increasing functional residual capacity and decreasing respiratory system elastance, principally in the obese subjects. Furthermore, the application of recruiting maneuver followed by the subsequent application of PEEP improved oxygenation during laparoscopy. Cinnella et al. demonstrated that an open lung strategy, i.e. a ventilation supported by recruiting maneuvers followed by the subsequent application of PEEP applied after pneumoperitoneum induction, increased transpulmonary pressure and led to alveolar recruitment and improvement of elastance of chest wall and gas exchange. These results are in accordance with finding by Talmor et al, evaluating the effect of a mechanical ventilation guided by esophageal pressure in acute lung injury patients.
However a comparison between an esophageal pressure piloted mechanical ventilation and a conventional low tidal ventilator strategy with adjunct of PEEP and recruitment maneuvers according to clinical judgment has never been investigated in patients undergoing robotic gynecologic, abdominal or urologic surgery.
Aim The investigators aim to compare the conventional ventilation strategy (i.e., with application of PEEP and recruitment manoeuvre) with a ventilation driven by transpulmonary pressure assessed through an esophageal catheter, in patients undergoing to robotic surgery, with respect to oxygenation, expressed in terms of arterial oxygen tension - inspired oxygen fraction ratio (PaO2/FiO2) (primary endpoint), intraoperative respiratory mechanics indexes, number of lung recruitment maneuvers, rate and type of perioperative complications until hospital discharge (additional endpoint).
METHODS Patients For this protocol, after informed consent has been obtained, 26 patients will be enrolled in the pilot randomized interventional study, eligible for robotic gynecological, urological and abdominal surgery at Maggiore Hospital Novara Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Patients will not know the arm of assignment. Care providers and investigators will know the arm, making the masking not possible.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) score I - II
- •Patients requiring elective robotic gynecological-abdominal surgery
排除标准
- •Contraindications to the positioning of a naso-gastric tube
研究组 & 干预措施
conventional ventilation strategy
13 patients will undergo volume controlled ventilation set with a tidal volume between 6-8 ml/kg of ideal body weight, positive end-expiratory pressure and fraction of inspired oxygen set to obtain a peripheral saturation in oxygen equal or greater than 94% and a plateau pressure <28 cmH2O.
干预措施: Conventional ventilation strategy (Procedure)
transpulmonary pressure strategy
13 patients will undergo volume controlled ventilation set with a tidal volume at 6-8 ml/kg of ideal body weight, and with a inspiratory transpulmonary pressure less than 20 cmH2O and an expiratory transpulmonary pressure and inspired oxygen set accordingly to predefined criteria.
干预措施: Transpulmonary pressure driven ventilation strategy (Procedure)
结局指标
主要结局
Oxygenation Changes
时间窗: Soon after anesthesia induction (step 1), after 45 min from step 1 (pneumoperitoneum, trendelemburg, recruitment maneuver application-step 2),after 20min from randomization (step 3), every 60 min during surgery and at its end, after 1 hour from recovery.
Ratio between the arterial partial pressure (PaO2) and inspired fraction (FiO2) of oxygen (PaO2/FiO2)
次要结局
- Number of lung recruitment maneuvers(During the whole surgical procedure)
- Rate of perioperative complications(within the following 30 days after surgery)
- Intraoperative respiratory mechanics indexes changes(Soon after anesthesia induction (step 1), after 45 min from step 1 (pneumoperitoneum, trendelemburg, recruitment maneuver application-step 2),after 20min from randomization (step 3), every 60 min during surgery and at its end, after 1 hour from recovery.)
- Type of perioperative complications(within the following 30 days after surgery)
研究者
Gianmaria Cammarota
Physician in staff of the ICU
Azienda Ospedaliero Universitaria Maggiore della Carita
