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临床试验/NCT03019354
NCT03019354Unknown不适用

The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Chest CT image atelectatic area

研究概览

简要总结

In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It has physiological effects: reduction of anatomical dead space, positive end expiratory pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis.

详细描述

After general anesthesia, almost 90% patients have lung atelectasis. The lung atelectasis persisted even after the surgery, and caused post operative complication, for example: fever, pleural effusion, hypoxemia, pneumonia, and respiratory failure. So, how to improve lung function after the surgery is a important issue. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It provides respiratory support: 1. Reduction of dead Space by clearance of expired air in the upper airways. 2. Delivering positive airway pressure. 3. delivering optimal humidity, which helps maintain function of the mucociliary transport system, clearing secretions and reducing the risk of infections. Many reports suggest that high-flow nasal cannula decreases breathing frequency and work of breathing and reduces intubation rate in critical ill patients. Although high-flow nasal cannula was used widely in intensive care unit (ICU) , there are no enough evidence in patients under general anesthesia. The hypothesis of this study is that using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis. Liver tumor radiofrequency ablation was performed sometimes in patients under general anesthesia. Intravenous general anesthesia is one of the anesthesia choice. Oxygen mask is the traditional oxygen delivery system. Apnea, hypoxemia, and CO2 retention are common situation in intravenous general anesthesia. So high-flow nasal oxygen is an ideal oxygen delivery system in intravenous general anesthesia. This randomized control study will enroll patients receiving CT guided liver tumor radiofrequency ablation under general anesthesia. One group will receive high-flow nasal oxygen, the other group will receive traditional oxygen mask. The primary outcome is lung atelectasis area in CT scan. The secondary outcome is respiratory function (for example: arterial blood gas, lung injury biomarkers, saturation, postoperative pulmonary complication)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Patients with hepatic tumor undergoing CT guided radiofrequency ablation
  • •Age > 20 years old

排除标准

  • •Cardiac dysfunction, such as heart failure > NYHA class II, coronary arterial disease
  • •Impaired renal function, cGFR< 60 ml/min/1.73 m2
  • •Pulmonary disease

研究组 & 干预措施

high-flow nasal oxygen

Experimental

high-flow nasal oxygen was used during intravenous general anesthesia

干预措施: high-flow nasal oxygen (Device)

Oxygen mask

Active Comparator

oxygen mask was used during intravenous general anesthesia

干预措施: Oxygen mask (Device)

结局指标

主要结局

Chest CT image atelectatic area

时间窗: At the end of surgery

lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.

次要结局

  • lung injury(At the end of surgery)
  • postoperative pulmonary complications(within the first 7 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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