Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comfort evaluation using self introduction questionnaire
研究概览
简要总结
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.
详细描述
This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.
The testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind, order randomized study. All cannulas will be numbered. The investigators, the outcomes assessors and the subjects will be blind to the identity of the cannulas. The order of which the subjects will assess the cannulas will be randomized.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Men and Women
- •Age 50-85
- •Willingness to participate in the study
排除标准
- •Women who are pregnant or breastfeeding
- •Subjects with sensitivity to any of the products or the its ingredient
- •Subjects with sensitivity to preparation for testing bacterial plaque
- •Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment
- •Subjects who are treated with Anti-thrombotic agents
研究组 & 干预措施
Model 1
Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula
干预措施: Oridion Smart CapnoLine® H Plus with Wedge cannula (Device)
Model 2
Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula
干预措施: Oridion Smart CapnoLine® Plus with Non-Wedge cannula (Device)
Model 3
Device - Experimental sample line Model 3
干预措施: Experimental sample line Model 3 (Device)
Model 4
Device - Experimental sample line Model 4
干预措施: Experimental sample line Model 4 (Device)
Model 5
Device - Experimental sample line Model 5
干预措施: Experimental sample line Model 5 (Device)
Model 6
Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)
干预措施: O2/CO2 cannula w/female luer (Westmed comfort plus #0504) (Device)
结局指标
主要结局
Comfort evaluation using self introduction questionnaire
时间窗: 3 months
Measuring comfort on a scale of 1 -7, where 1 = not comfortable, 7 = very comfortable Data will be reported using self introduction questionnaires in different time intervals
次要结局
- Comfort evaluation using self introduction questionnaire - calculations(3 months)