Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome: Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- intraoperative oxygenation
研究概览
简要总结
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.
Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against PPCs.
Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults.
We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.
详细描述
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.
In GroupVar VT will be 6 ml/kg predicted body weight ±33% with 5 cmH2O PEEP. Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.
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
- •Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
- •BMI < 35 kg/m2
- •Age ≥ 18 years
- •Expected duration of surgery > 60 min
- •Expected duration of anesthesia > 90 min
排除标准
- •COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- •uncontrolled asthma
- •NYHA 3+4, CCS 3+4
- •previous thoracic surgery
- •ARDS (Berlin definition)
- •documented pulmonary arterial hypertension > 40 mmHg syst
- •documented or suspected neuromuscular disease (thymoma, myasthenia)
- •planned mechanical ventilation after surgery
- •bilateral procedures
- •lung separation with other method than DLT (eg diff. airway, tracheostomy)
- •surgery in prone position
- •persistent hemodynamic instability, intractable shock
- •intracranial injury or tumor
- •enrollment in other interventional study or refusal of informed consent
- •pregnancy (excluded by anamnesis and/or laboratory analysis)
研究组 & 干预措施
GruopFix
one-lung ventilation with constant tidal volume
GroupVariable
one-lung ventilation with variable tidal volume Intervention: change of ventilatory settings
干预措施: change of ventilatory settings (Other)
结局指标
主要结局
intraoperative oxygenation
时间窗: 1 day
PaO2 \< 60 mmHg
次要结局
- postoperative pulmonary complications(90 days)
- postoperative extra-pulmonary complications(90 days)
- 30-day survival/mortality(30 days)
- 90-day survival/mortality(90 days)
研究者
Tamas Vegh, MD
Head, Division of General, Vascular and Thoracic Anesthesia
University of Debrecen