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临床试验/NCT02473068
NCT02473068已完成不适用

Non Invasive Ventilation Comfort Study

Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年6月19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
28
试验地点
2
主要终点
Participant Comfort Questionnaire

研究概览

简要总结

Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.

详细描述

Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form

排除标准

  • Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
  • Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form

研究组 & 干预措施

Group 1

Active Comparator

In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C.

干预措施: CPAP (Device)

Group 2

Experimental

In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C.

干预措施: CPAP (Device)

结局指标

主要结局

Participant Comfort Questionnaire

时间窗: 30 Minutes

Participant answers questions to indicate comfort

次要结局

未报告次要终点

研究者

发起方
Fisher and Paykel Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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