NCT01300845已完成不适用
Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2011年3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
- 发起方
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- A score of comfort assessed with a detailed and specific questionnaire
研究概览
简要总结
In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Admission in Intensive Care Unit
- •Oxygen therapy started for less than two hours in ICU
排除标准
- •Age under 18
- •Pregnancy
- •Participation in other trials with the same endpoints
- •absence of registration in french health care system
- •patient protected by law
- •tracheotomised or intubated patient
- •Patient with non invasive ventilation
- •Oxygen therapy started for more than two hours in ICU
研究组 & 干预措施
No Humidification
Experimental
干预措施: No Humidification (Procedure)
Humidification
Active Comparator
干预措施: Humidification (Procedure)
结局指标
主要结局
A score of comfort assessed with a detailed and specific questionnaire
时间窗: This score is assessed between the sixth and the eighth hour after randomization
This score is built from answers brought in a questionnaire including 15 items. Each item can be rated from 0 to 10, allowing to increment a score on 150 points.
次要结局
- Percentage of patients requiring a fibroscopic aspirations during their stay in intensive care unit or USC within the limits of 28 days.(Department discharge limited by day 28)
- Percentage of patients who had an ear, nose and throat infections during their stay in intensive care unit or USC within the limits of 28 days.(Department discharge limited by day 28)
- mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.(Department discharge limited by day 28)
- Percentage of patients requiring an intubation during their stay in intensive care unit or USC within the limits of 28 days.(Department discharge limited by day 28)
- The specific scores of comfort for each items(Hour 6-8)
- Observance level for oxygen therapy(Hour 6-8)
- The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days(Department discharge limited by day 28)
- The length of stay in intensive care unit or USC(Department discharge limited by day 28)
研究者
研究点 (1)
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