Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 984
- 试验地点
- 16
- 主要终点
- Acute Respiratory Distress Syndrome (ARDS) incidence
研究概览
简要总结
The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) based on low tidal volume, PEEP and alveolar recruitment maneuver can reduce Acute Respiratory Distress Syndrome (ARDS) and Postoperative pulmonary complications (PPCs) after major pulmonary resection.
Primary endpoint: Evaluation of postoperative ARDS incidence
Secondary endpoint: Evaluation od PPC incidence and postoperative outcomes (other complications, unplanned Intensive Care Admission, hospital and ICU length of stay, in-hospital mortality)
详细描述
Pulmonary postoperative complications (PPCs) are the most frequent adverse events after thoracic surgery. Acute respiratory distress syndrome (ARDS) is the most severe among PPCs. Injurious mechanical ventilation is a recognized risk factor associated with ARDS and PPCs after major thoracic surgery.
International literature reports a wide use of tidal volume around 5-6 ml/kg predicted body weight (PBW) during one lung ventilation (OLV) but variable use of PEEP and alveolar recruitment maneuver (ARM).
The aim of this multicenter, randomized, single blind study is to determine if a protective ventilatory strategy during OLV based on low tidal volume, PEEP and alveolar recruitment maneuver compared to conventional strategy can reduce ARDS and PPCs after major pulmonary resection.
Primary outcome is the incidence of in-hospital ARDS.
Secondary outcomes are in-hospital incidence of postoperative pulmonary complications (PPCs), major cardiovascular events, unplanned Intensive Care Unit admission, in-hospital length of stay and mortality
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
- Single (Participant)
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
- •Patients ≥ 18 years
- •Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)
排除标准
- •Emergency surgery
- •Wedge resection or atypical resection
- •Non-resective lung surgery requiring OLV
- •Patients < 18 years
- •BMI < 20 and BMI > 29
- •Heart disease with ejection fraction <50% and/or severe valvulopathy
- •Pulmonary hypertension
- •Renal failure requiring dialytic treatment
- •Drug addiction
- •Mental retardation, depression and psychiatric disease
- •Motor or sensory deficit
- •Pregnancy
研究组 & 干预措施
Protective
Two-lung ventilation (TLV): tidal volume = 8 mL / kg PBW, peak airway pressure ≤ 25 cm H2O, I: E = 1:2; after lung re-expansion to the closure of the chest will set a PEEP of 5 cmH2O
OLV (OLV): 4 mL / kg PBW, peak airway pressure ≤ 35 cmH2O, respiratory rate <30, I:E = 1:2 / 1:3.
During OLV in case of desaturation (before increasing the FiO2) and every 60 minutes alveolar recruitment maneuvers followed by the setting of PEEP to 5 cmH2O
干预措施: Protective one lung ventilation (Procedure)
Conventional
Two-lung ventilation (TLV): tidal volume = 8 mL / kg PBW, peak airway pressure ≤ 25 cmH2O; I: E = 1:2; after lung re-expansion to the closure of the chest PEEP set to 5 cmH2O
OLV (OLV): 6 mL / kg PBW, peak airway pressure ≤ 35 cmH2O; I: E = 1:2.
结局指标
主要结局
Acute Respiratory Distress Syndrome (ARDS) incidence
时间窗: Hospital stay (7 days average expected)
incidence of ARDS (%)
次要结局
- Postoperative pulmonary complications (PPCs)(Hospital stay (7 days average expected))
- In-hospital mortality(Hospital stay (7 days average aspected))
- Postoperative complications(Hospital stay (7 days average expected))
- Unplanned Intensive Care Unit (ICU) admission(Hospital stay (7 days average aspected))
- Intensive Care Unit (ICU) Length of stay(Hospital stay (7 days average aspected))
- Length of hospital stay(Hospital stay (7 days average expected))
研究者
Giorgio Della Rocca
M.D.
Azienda Ospedaliera S. Maria della Misericordia