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Noninvasive Ventilation After Coronary Bypass Grafting (Physiotherapy)

2015年1月28日 更新者:Célia Regina Lopes、Federal University of Uberlandia

Effects of Non Invasive Ventilation on Heart Rate Variability After Coronary Bypass Grafting: Comparison Between Different Ventilator

This is a prospective, quantitative, randomized, crossover study. Were included in this study 10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the first day of the postoperative coronary artery bypass graft (CABG). For data collection was performed randomization on the block (2: 4), to determine the first technique to be used and then a wash-out period of one hour was allowed for the research subject reaches the systemic arterial pressure, heart rate, respiratory rate and oxygen saturation baseline. And after, for cross-over, the second technique was performed. Non-invasive ventilation was performed for 30 minutes each ventilator. All subjects underwent noninvasive ventilation using two models of ventilators, they are conventional (designed for invasive ventilation but is also used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation). Hemodynamic, autonomic and respiratory variables are monitored. We use the hypothesis that non-invasive ventilation performed with two fan models can alter autonomic function and that there is hemodynamic changes related to autonomic function in different ventilators in postoperative coronary artery bypass grafting.

研究概览

详细说明

Background: The patients in postoperative coronary artery bypass graft (CABG) have impaired cardiac autonomic function. However, no studies have evaluated the influence of different ventilators during noninvasive ventilation (NIV) in the autonomic modulation associated with hemodynamic changes. Objective: Evaluate the autonomic behavior and hemodynamic changes during the execution of the NIV with two models of mechanical ventilators in subjects after CABG. Material and Methods: This is quantitative randomized, prospective, crossover study. The subjects were selected on first day postoperatively CABG and was performance NIV procedure using two different ventilators: conventional ventilator and specific ventilator for the use of NIV for 30 minutes, each. Block randomization was used to determine the technique that begins to approach then by crossover, perform the sequential technique. The heart rate variability (HRV), heart rate, respiratory rate, oxygen peripheral saturation and arterial pressure were evaluated before procedure, in the instants 5, 10, 15, 20, 25, 30 minutes during NIV each and 15 minutes after the end of the NIV application. HRV was evaluated using the time and frequency domain.

研究类型

介入性

注册 (实际的)

10

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion criteria

  • Age over 18 years .Who were breathing spontaneously with peripheral oxygen saturation (SpO2) ≥ 90% and supplemental oxygen ≤ 3 l / min.
  • Indication for use of NIV

Exclusion criteria

  • Hemodynamic instability with hypertensive response being considered systolic blood pressure (SBP) greater than 180 mmHg and diastolic blood pressure (DBP) greater than 110 mmHg, or difference in SBP and DBP less than 20 mmHg or framework shock considering SBP <90 mmHg and / or DBP <50 mmHg, since the normal SBP were between 90-130 mmHg and DBP 60-90 mmHg
  • Presence of active cardiac pacemaker
  • Invasive mechanical ventilation more than 24 hours
  • Use of intra aortic balloon
  • Postoperatively Myocardial infarction after surgery
  • Ineffective cough with bronchial hypersecretion
  • Inability to adequately swallowing and/or protect the airway
  • Abdominal distension
  • Nausea
  • Vomiting

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Conventional ventilator
30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak
其他:Specific ventilator
30 minutes of non-invasive ventilation was performed with specific respirator. The order of the procedures was determined by randomization.
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Variability of heart rate front the use of noninvasive ventilation in two different ventilators in patients after cardiac surgery, measured by Polar RS800 CX.
大体时间:3 hours
The autonomic variables evaluated are: standard deviation of all normal RR intervals recorded in a time interval (SDNN); standard deviation of the mean of normal RR intervals every 5 minutes at a time, expressed in milliseconds (SDANN); percentage of R-Ri with adjacent difference of duration greater than 50 milliseconds (pNN50) and the square root of the average squared difference between the adjacent R-Ri normal in a period of time, expressed in milliseconds (rMSSD). All variables will be assessed by Polar RS800CX
3 hours

次要结果测量

结果测量
大体时间
Change in the indices of variability of heart rate, systolic blood pressure, diastolic blood pressure and heart rate during noninvasive ventilation with two models of ventilatotors in patients after cardiac surgery.
大体时间:3 hours
3 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Valdeci C Dionísio, Dr.、Federal University of Uberlandia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年3月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2014年11月10日

首先提交符合 QC 标准的

2015年1月28日

首次发布 (估计)

2015年2月2日

研究记录更新

最后更新发布 (估计)

2015年2月2日

上次提交的符合 QC 标准的更新

2015年1月28日

最后验证

2015年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 11104413.6.0000.5152

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Conventional ventilator的临床试验

3
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