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临床试验/NCT01917526
NCT01917526已完成不适用

The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.

Mahidol University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Number of Participants With Hypoxemia in Both Groups

研究概览

简要总结

After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.

This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.

详细描述

The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •General anesthesia
  • •Age 18-70 years
  • •American Society of Anesthesiology (ASA)physical status 1-3
  • •Elective case

排除标准

  • •ASA physical status class 4 or more
  • •Unstable pulmonary diseases
  • •BMI > 35 kg/m2
  • •oxygen saturation < 94% when breathing in room air
  • •Respiratory muscle weakness eg.myasthenia gravis
  • •Central nervous system abnormalities eg.drowsiness, hypoventilation
  • •Patients who have been intubated or needed ventilatory support before operation
  • •Plan to remain intubated after the operation
  • •Intracranial, intrathoracic and upper abdomen surgery
  • •Patients who nasogastric tube is inserted
  • •Airway problems eg. sinusitis
  • •Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery
  • •Patient refusal

研究组 & 干预措施

oxygen mask

Active Comparator

Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.

干预措施: oxygen mask (Device)

Oxygen cannula

Active Comparator

Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.

干预措施: oxygen cannula (Device)

结局指标

主要结局

Number of Participants With Hypoxemia in Both Groups

时间窗: In PACU (1 hr after anesthesia)

Hypoxemia is defined as oxygen saturation \< 94%. We record number of participants with hypoxemia in both groups

次要结局

  • The Causes of Hypoxemia(In PACU (1 hr after anesthesia))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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