跳至主要内容
临床试验/NCT02767687
NCT02767687已完成不适用

Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery

Federal University of São Paulo0 个研究点目标入组 80 人开始时间: 2013年9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
80
主要终点
Evaluation of central venous oxygen saturation to determine tissue perfusion

研究概览

简要总结

This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.

详细描述

Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.

Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.

This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Presence of central venous catheter
  • Invasive arterial pressure catheter
  • Invasive mechanical ventilation

排除标准

  • Chronic obstructive pulmonary disease
  • Morbid obesity
  • Hemodynamic instability
  • Spontaneous breathing
  • Need of invasive mechanical ventilation for more than 24 hours
  • Intolerance to noninvasive mechanical ventilation
  • Extubation failure

结局指标

主要结局

Evaluation of central venous oxygen saturation to determine tissue perfusion

时间窗: Through study completion, an average of 1 year

All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.

Evaluation of arterial lactate to determine tissue perfusion

时间窗: Through study completion, an average of 1 year

All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.

次要结局

  • Respiratory complications during hospitalization(Through study completion, an average of 1 year)
  • Hemodinamycs complications during hospitalization(Through study completion, an average of 1 year)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasha de Oliveira Marcondi

Principal Investigator

Federal University of São Paulo

相似试验

Influence of Non Invasive Mechanical Ventilation on... | 临床试验