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临床试验/NCT04813250
NCT04813250已完成不适用

The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery

National Defense Medical Center, Taiwan2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018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
50
试验地点
2
主要终点
The correlation between Different ventilation mode and the relevant value of EIT

研究概览

简要总结

Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.

详细描述

The aim of this study is to use four different ventilatory strategies 【Group R : IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) ; Group RP, Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O ;Group RI : Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1) ;Group RPI: Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)】 to compare the beneficial in decreasing the incidence of post-operative pulmonary dysfunction after cardiac surgery including of the data of EIT, GAS , Lactate , PFR:PaO2/FiO2 ratio , cardiac index (CI) , BMI..etc . EIT were measured at two perioperative timepoints 1. after intubation at the onset of anesthesia with mechanical ventilation with 7ml/ kg (Predicted body weight) 2. at the end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

De-identify the data before analyse the data by outcome saaessor

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-80 year-old
  • Adult patients receiving elective cardiac surgery with hypothermic CPB

排除标准

  • Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation

结局指标

主要结局

The correlation between Different ventilation mode and the relevant value of EIT

时间窗: since weaning cardiopulmonary bypass (CPB) to the end of surgery

Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient

The demographic characteristics and relevant value of EIT

时间窗: since weaning cardiopulmonary bypass (CPB) to the end of surgery

Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient

次要结局

  • If the different ventilation mode setting can improve clinical outcome(since weaning cardiopulmonary bypass (CPB) to the end of surgery)
  • The correlation between heart function & oxygenation and different ventilation mode(since weaning cardiopulmonary bypass (CPB) to the end of surgery)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yung-Chi Hsu

Attending Physician of Department of Anesthesiology

Tri-Service General Hospital

研究点 (2)

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