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Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

2018年5月25日 更新者:Tufts Medical Center
The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh, PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for the emergency treatment of patients with acute respiratory failure with the machine blowing air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).

研究概览

详细说明

Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.

The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.

The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.

研究类型

介入性

注册 (实际的)

60

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、02111
        • Tufts Medical Center
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital

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:

  • Age>18
  • Either A or B

A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.

B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.

Exclusion Criteria:

  • The need for immediate intubation
  • Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
  • Agitation or uncooperativeness, unresponsive to small doses of sedatives
  • Excretions or inability to protect the airway
  • Inability to fit the mask
  • Facial trauma
  • Upper airway obstruction

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:治疗
  • 分配: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
实验性的:1
Patients receiving NPPV by the 'Total Face Mask'
NPPV is applied by this mask, as long as NPPV is received.
其他名称:
  • cephalic mask
有源比较器:2
Patients receiving NPPV by 'standard oronasal mask'
NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
其他名称:
  • Full face mask

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
大体时间:During the first 3 hours of recruitment
During the first 3 hours of recruitment
Time Required for Mask Placement
大体时间:at the initiation of NPPV
at the initiation of NPPV

次要结果测量

结果测量
措施说明
大体时间
Early NIV Discontinuation Rate
大体时间:During hospitalization period (after recruitment into the study)
Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
During hospitalization period (after recruitment into the study)
Deterioration Vital Signs
大体时间:during the first 24 hours of the study
during the first 24 hours of the study
Deterioration in Gas Exchange
大体时间:during the first 24 hours of the study
during the first 24 hours of the study
Total Length of Time Requiring NIV
大体时间:during hospitalization (after recruitment)
during hospitalization (after recruitment)
Length of Hospital Stay
大体时间:during hospitalization (after recruitment)
during hospitalization (after recruitment)
In-hospital Mortality Rate
大体时间:during hospitalization (after recruitment)
during hospitalization (after recruitment)

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。

调查人员

  • 学习椅:Aylin Ozsancak, MD、Research Fellow
  • 首席研究员:Nicholas S. Hill, MD、Chair of Pulmonary, Critical Care and Sleep Division
  • 研究主任:Samy Sidhom, MD, MPH、Clinical Fellow

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

2003年1月1日

初级完成 (实际的)

2008年6月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2008年5月27日

首先提交符合 QC 标准的

2008年5月28日

首次发布 (估计)

2008年5月29日

研究记录更新

最后更新发布 (实际的)

2018年6月25日

上次提交的符合 QC 标准的更新

2018年5月25日

最后验证

2018年5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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