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临床试验/NCT04032366
NCT04032366Unknown不适用

Inhaled Nitric Oxide as Salvage Treatment of Hypoxemia After Type A Acute Aortic Dissection Surgery (INSTEAD)

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Intrapulmonary shunt with a PEEP of 5 cm H2O

研究概览

简要总结

The purpose of this study was to clarify the possible mechanism of hypoxemia after surgical treatment of type A acute aortic dissection and the possible mechanism of the treatment role of inhaled nitric oxide in refractory hypoxemia.

详细描述

The investigators' previous study has stressed that inhaled nitric oxide therapy might play an ameliorative role in patients with refractory hypoxemia after surgical treatment of type A acute aortic dissection. The possible reason might be the decreasing of intrapulmonary shunt because previous studies showed that inhaled nitric oxide could decrease intrapulmonary shunt by selectively dilating the pulmonary vessels in ventilated areas. As a result, the investigators designed this observational study to calculate the intrapulmonary shunt before and after inhaled nitric oxide therapy. Intrapulmonary shunt was calculated from oxygen content (CO2) of different sites ( artery, mixed venous, alveolar capillary) by Fick equation:(CaO2-CcO2)/(CvO2-CcO2). A FiO2 of 1.0 and tidal volume of 6~8 ml/kg were chosen. Oxygen content was calculated from hemoglobin (Hb), oxygen saturation (SO2) and oxygen partial pressure (PO2) by the following equation: CO2 = 1.34*Hb*SO2 + 0,0031*PO2. PaO2, SaO2, PvO2 and SvO2 were measured from arterial and mixed venous blood samples taken from the radial arterial catheter and from the pulmonary artery catheter. ScO2 was estimated to be 1.0 with a FiO2 of 100%. PcO2 was considered to be the same as PAO2 (partial pressure of oxygen in the alveoli), and was calculated from the alveolar gas equation with PAO2 = [(atmospheric pressure - 47) * (FiO2)] - PaCO2/0.8.Other variables such as hemodynamic variables from pulmonary artery catheter were also collected.

研究设计

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

入排标准

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

入选标准

  • Type A aortic dissection;
  • After surgery;
  • P/F ratio ≤ 200mmHg

排除标准

  • Intracardiac shunt;
  • Contradiction of PAC;
  • Chronic pulmonary diseases before surgery;
  • Anticipation of death within 48 hours after operation;

研究组 & 干预措施

PEEP 10

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 10cm H2O, without inhaled nitric oxide

干预措施: inhaled nitric oxide (Drug)

PEEP 10

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 10cm H2O, without inhaled nitric oxide

干预措施: PEEP (Device)

PEEP 5 +iNO

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, with inhaled nitric oxide

干预措施: inhaled nitric oxide (Drug)

PEEP 5 +iNO

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, with inhaled nitric oxide

干预措施: PEEP (Device)

结局指标

主要结局

Intrapulmonary shunt with a PEEP of 5 cm H2O

时间窗: 6 to 24 hours after surgery

intrapulmonary shunt calculated by Fick equation with a PEEP of 5 cm H2O

Intrapulmonary shunt with a PEEP of 10 cm H2O

时间窗: 30 minutes after increasing PEEP to 10cm H2O

intrapulmonary shunt calculated by Fick equation with a PEEP of 10 cm H2O

Intrapulmonary shunt with inhaled nitric oxide and a PEEP of 5 cm H2O

时间窗: 30 minutes after decreasing PEEP to 5cm H2O

intrapulmonary shunt calculated by Fick equation with inhaled nitric oxide and a PEEP of 5 cm H2O

Intrapulmonary shunt with a PEEP of 10 cm H2O and inhaled nitric oxide

时间窗: 30 minutes after inhaling nitric oxide

intrapulmonary shunt calculated by Fick equation with a PEEP of 10 cm H2O and inhaled nitric oxide

次要结局

  • cardiac output collected from PAC with a PEEP of 5 cm H2O(6 to 24 hours after surgery)
  • cardiac output collected from PAC with a PEEP of 10cm H2O(30 minutes after increasing PEEP to 10cm H2O)
  • pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide(30 minutes after inhaling nitric oxide)
  • pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O(6 to 24 hours after surgery)
  • pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O(6 to 24 hours after surgery)
  • pulmonary artery pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O(30 minutes after decreasing PEEP to 5 cm H2O)
  • pulmonary artery wedge pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O(30 minutes after decreasing PEEP to 5 cm H2O)
  • pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O(30 minutes after increasing PEEP to 10cm H2O)
  • cardiac output collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide(30 minutes after inhaling nitric oxide)
  • cardiac output collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O(30 minutes after decreasing PEEP to 5 cm H2O)
  • pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O(30 minutes after increasing PEEP to 10cm H2O)
  • pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide(30 minutes after inhaling nitric oxide)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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