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临床试验/NCT03435913
NCT03435913已完成不适用

Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure (PEEP) During Laparoscopic Surgery

Hospital Universitario La Fe1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation

研究概览

简要总结

Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery.

Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship.

At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) risk scale I to III
  • Age > 18 years
  • Previously signed informed consent
  • Undergoing laparoscopic surgery

排除标准

  • Pregnancy
  • Advanced liver, kidney or cardiopulmonary disease

结局指标

主要结局

Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation

时间窗: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure

次要结局

  • Pulmonary Stress index difference(Pneumoperitoneum insufflation before surgery (up to 30 minutes))
  • Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).(Pneumoperitoneum insufflation before surgery (up to 30 minutes))
  • Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)(Pneumoperitoneum insufflation before surgery (up to 30 minutes))
  • Chest wall compliance (CCw) difference(Pneumoperitoneum insufflation before surgery (up to 30 minutes))
  • Respiratory system compliance (Crs) difference between standard and matched PEEP levels(Pneumoperitoneum insufflation before surgery (up to 30 minutes))
  • Pulmonary compliance (Cp) difference(Pneumoperitoneum insufflation before surgery (up to 30 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Diaz-Cambronero

Anesthesiology Consultant

Hospital Universitario La Fe

研究点 (1)

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