A Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy in Healthy Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Regional Distribution of Ventilation
研究概览
简要总结
The primary purpose of this study is to determine if there is a significant difference in regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects. Electrical impedance tomography (EIT) will be used to measure regional distribution of ventilation during resting tidal ventilation and during lung expansion therapy.
详细描述
Investigators will use a convenience sampling scheme to identify potential study participants. Documentation of informed consent will be recorded. Electrical Impedance Tomography (Pulmovista 500; Draeger, Lubeck, Germany), which provides non-invasive and radiation free monitoring, will be used to monitor and measure regional distribution of ventilation during I.S and EzPAP® lung expansion therapy.
Recruitment email will be will be sent to University of Virginia Medical Center employees who represent the target study population. A university of Virginia email distribution list will be used to mass email respiratory therapy and nursing staff working in adult ICU and surgical acute care patient wards. Word of mouth will also be used to heighten awareness about this study.
A computer generated random numbers generator will be used to randomly assign study subjects into an I.S. or EzPAP® lung expansion therapy group after documentation of informed consent has been recorded. Randomization masking/blinding will not occur in this study. The lung expansion therapy medical device designs and their respective operational differences are impossible to conceal.
Procedure set-up and device calibration will occur according to Draeger provided PulmoVista 500 (Draeger; Lubeck, Germany) EIT training and operation manual:
- Study participant preparation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy- not receiving in-patient medical care
- •Documentation of written informed consent
排除标准
- •Less than 18 or greater than 79 years of age
- •Body mass index > 50
- •Excessive chest hair
- •Inability to obtain written informed consent
- •Inability to follow verbal instructions
- •Pregnancy: self reported
- •Uncontrolled body movements
- •Inability to place EIT electrodes and belt in direct contact with skin where they are projected to come into contact
- •Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]), or when device compatibility is in doubt.)
研究组 & 干预措施
Volumetric Incentive Spirometry
Incentive Spirometry
干预措施: Volumetric Incentive Spirometry (Device)
EzPAP® POSITIVE AIRWAY PRESSURE
EzPAP
干预措施: EzPAP® POSITIVE AIRWAY PRESSURE (Device)
结局指标
主要结局
Regional Distribution of Ventilation
时间窗: 2 months
EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.
次要结局
未报告次要终点
研究者
Daniel D Rowley
Principal Investigator
University of Virginia