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Investigation of Efficiency of Breathing With Different Breathing Patterns

2014年12月1日 更新者:Yandong Jiang、Massachusetts General Hospital

Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure

Our aim in this study is to investigate the efficiency of the breathing with different breathing patterns. Ten volunteers and twenty patients having respiratory problems will be coached on their breathing through specific masks which will provide four different breathing patterns. These patterns will be 1) Breathing in through the nose only and out through the mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing in and out through the nose only 4) Breathing in and out through the mouth only The data obtained from volunteers and patients will be compared within and between the groups.

研究概览

研究类型

介入性

注册 (实际的)

26

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital, Respiratory Care Laboratory

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • For healthy subjects:

    1. Ten healthy adult (> 18 years of age) volunteers will be recruited from the MGH main campus through intra-hospital e-mail broadcasting. Subjects with the following issues will be excluded from the study.

  • For patients with respiratory insufficiency:

    1. Twenty adult (> 18 years of age) patients will be recruited. These patients will be either patients in acute respiratory failure resulting from COPD exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the MGH; or patients with diagnosed stable COPD on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the MGH as study subjects.

Exclusion Criteria:

  • For healthy volunteers:

    1. Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
    2. Subjects who have claustrophobia and cannot wear the mask.
  • For patients with respiratory insufficiency:

    1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
    2. Patients who have claustrophobia and cannot wear the mask.
    3. Patients who are hemodynamically unstable.
    4. Patients requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Volunteers
Ten healthy volunteers

All subjects will breathe in four different breathing patterns which are provided by specific masks. Patterns are as the following:

  1. Breathing in through the nose only and out through the mouth only
  2. Breathing in through the mouth only and out through the nose only
  3. Breathing in and out through the nose only
  4. Breathing in and out through the mouth only
其他:Patients
Sixteen patients with respiratory insufficiency

All subjects will breathe in four different breathing patterns which are provided by specific masks. Patterns are as the following:

  1. Breathing in through the nose only and out through the mouth only
  2. Breathing in through the mouth only and out through the nose only
  3. Breathing in and out through the nose only
  4. Breathing in and out through the mouth only

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Determining the anatomic dead space change at variable tidal volumes with four different breathing patterns (nose-in and nose-out, mouth-in and mouth-out, nose-in and mouth-out, mouth-in and nose-out) in healthy volunteers.
大体时间:3 months
3 months
Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
Comparing the efficiency of the study mask which forces subjects to breathe in a manner similar to pursed lip breathing and a regular facemask in healthy volunteers and patients with respiratory failure
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年11月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2011年6月1日

研究注册日期

首次提交

2008年10月30日

首先提交符合 QC 标准的

2008年10月31日

首次发布 (估计)

2008年11月2日

研究记录更新

最后更新发布 (估计)

2014年12月2日

上次提交的符合 QC 标准的更新

2014年12月1日

最后验证

2014年12月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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