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临床试验/NCT03551899
NCT03551899已完成不适用

An Observational Study of Intra-operative Ventilatory Management & Post-operative Pulmonary Complications

American University of Beirut Medical Center2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2017年2月24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
218
试验地点
2
主要终点
Intra-operative surgical procedures

研究概览

简要总结

Background: The list of studies with inconsistent data regarding the effect of intra-operative ventilatory management on post-operative lung injury is large. The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation.

Specific Aim: The aims of this study is first to describe intra-operative ventilatory practices at the American University of Beirut Medical Center (AUBMC), (with particular focus on the mode of ventilation, tidal volume per body weight and PEEP settings) and second, to identify the post-operative complications that could be associated with particular settings.

Methodology: This is a prospective observational study that will be conducted in the operating room at AUBMC, on patients being admitted for surgeries under general anesthesia. During the patient's stay in the hospital, targeted process (patient characteristics, surgical procedure, mechanical ventilation management, anesthesiologist characteristics) and outcomes parameters (postoperative pulmonary complications) will be collected for analysis. Patients will be monitored and followed up with intraoperatively and postoperatively.

Analysis: Different parameters and outcomes will be collected and by subgrouping the patients per their medical history statistical significance will be tested to reach a correlative analysis to the outcomes documented. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. Mean age, weight, height and BMI of participants in the different groups will be calculated. ANOVA test will be performed to test statistical significance to compare the different means between different subgroups. A two sided P value of less than 0.05 was considered to be significant Significance: The literature is lacking data on the least injurious way of ventilating surgical patients intra-operatively. This study is necessary to support future guidelines on the practice of intra-operative mechanical ventilation

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Intra-operative surgical procedures

时间窗: 2 hours

Type and duration (in minutes) of the surgical procedure

Intra-operative mechanical ventilation management

时间窗: 2 hours

Ventilation mode and settings

次要结局

  • Post-operative complications that could be associated with particular settings(1 week)

研究者

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

Jean berezian

Instructor of Anesthesia

American University of Beirut Medical Center

研究点 (2)

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