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临床试验/NCT02524522
NCT02524522已完成不适用

Perioperative Pulmonary Recruitment and Postoperative Monitoring of Integrated Pulmonary Index in Off-pump Coronary Bypass Grafting

Northern State Medical University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Duration of postoperative mechanical ventilation

研究概览

简要总结

This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.

详细描述

The outcome of elective off-pump coronary artery bypass grafting (OPCAB) can be significantly compromised due to early postoperative pulmonary complications. The risk of pulmonary complications including acute respiratory distress syndrome (ARDS), atelectases, and early ventilator-associated pneumonia remains inappropriate. Therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. Protocol-driven liberation from mechanical ventilation (CMV) can decrease the duration of CMV as well as the number of pulmonary complications. INTELLiVENT-Assisted spontaneous ventilation (INTELLiVENT-ASV) is a new approach, that may be as effective as conventional protocol-driven liberation from CMV.

In parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. One of the novel approaches to respiratory monitoring is Integrated Pulmonary Index (IPI). The Integrated Pulmonary Index merges four vital parameters including end-tidal carbon dioxide (EtCO2), respiratory rate, pulse rate, and oxygen saturation (SpO2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Informed consent.
  • Elective OPCAB.

排除标准

  • Participation in any other study.
  • Morbid obesity (BWI > 40).
  • The risk of pneumothorax after alveolar recruitment due to pulmonary emphysema.
  • Constant atrial fibrillation with pulse rate exceeding 100/min.
  • Inability to breathe easily through the nostrils and thus to gain good quality EtCO2 readings while breathing spontaneously, due to chronic rhinitis.

结局指标

主要结局

Duration of postoperative mechanical ventilation

时间窗: 24 hrs

Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs

次要结局

  • Reduced incidence of postoperative respiratory complications(up to 28 days postoperatively)
  • Duration of intensive care unit stay(72 hours)

研究者

发起方
Northern State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikhail Y. Kirov

Professor, head of Anesthesiology dept.

Northern State Medical University

研究点 (2)

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