Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intraoperative driving pressure
研究概览
简要总结
The purpose of this pilot study is to identify the optimal way to ventilate patients during abdominal surgery in order to reduce the amount of post-operative pulmonary complications in patients at moderate and high-risk for them.
详细描述
The investigators plan to prospectively compare two methods to individualize Positive End Expiratory Pressure (PEEP) settings in the operating room during abdominal surgery: (1) Maximization of respiratory compliance during a decremental PEEP titration, and (2) Prevention of negative end-expiratory transpulmonary pressures.
The investigators will exploit the usual intraoperative requirement for a naso/orogastric tube to assess transpulmonary pressures,and respiratory mechanics measurements from anesthesia machines to titrate PEEP.
The investigators will measure biomarkers of lung injury and lung function to compare those methods between themselves and to the control group. In the process, the investigators will assess the ease and reliability of anesthesia teams in implementing the methods. These data will allow us to determine the PEEP strategy best suited for the full-scale trial, and to estimate the degree of separation the experimental lung protective approach will have from the protocolized usual care control settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ( 18 years) scheduled for elective surgery expected to last 2 h,
- •elective intraperitoneal abdominal or pelvic surgery including: gastric; biliary; pancreatic; hepatic; major bowel, ovarian, renal tract, bladder, and prostatic; radical hysterectomy; and pelvic exenteration;
- •at least intermediate risk of PPCs defined by a risk score 26
排除标准
- •Inability or refusal to provide consent
- •Refusal of clinicians caring for patient to follow the protocol
- •Participation in interventional investigation within 30 days of the time of the study
- •Pregnancy
- •Emergency surgery
- •Severe obesity (above Class I, BMI 35)
- •Significant lung disease: any diagnosed or treated respiratory condition that (a) requires home oxygen therapy or non-invasive ventilation, (b) severely limits exercise tolerance to <4 METs (e.g. patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs), or (c) required previous lung surgery80
- •Significant heart disease: cardiac conditions that limit exercise tolerance to <4 METs
- •Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine 2 mg/dL;
- •Neuromuscular disease that impairs ability to ventilate without assistance
- •Severe chronic liver disease (Child-Pugh Score of 10 -15)
- •Malignancy or other irreversible condition for which 6-month mortality is estimated 50%
- •Bone marrow transplant.
研究组 & 干预措施
Conventional Strategy
Patients will receive usual and prudent PEEP and tidal volume settings.
Maximal Compliance Strategy
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
干预措施: Maximal Compliance (Other)
Transpulmonary Pressure Strategy
Personal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port
干预措施: Transpulmonary Pressure (Other)
结局指标
主要结局
Intraoperative driving pressure
时间窗: During abdominal surgery
We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.
Intraoperative respiratory system compliance
时间窗: During abdominal surgery
We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.
Intraoperative transpulmonary pressure
时间窗: During abdominal surgery
We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.
Intraoperative positive end-expiratory pressure (PEEP) levels
时间窗: During abdominal surgery
We will assess intraoperative PEEP values and their variability between patients and during surgery.
次要结局
- Intraoperative gas exchange(During abdominal surgery)
- Plasma levels of biomarkers of lung injury(During abdominal surgery)
- Postoperative Pulmonary Complications(Within the first 7 postoperative days.)
研究者
Marcos Vidal Melo
MD, PhD
Massachusetts General Hospital