Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
研究概览
地位
条件
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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'
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NPPV is applied by this mask, as long as NPPV is received.
其他名称:
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有源比较器:2
Patients receiving NPPV by 'standard oronasal mask'
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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:
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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
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During the first 3 hours of recruitment
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Time Required for Mask Placement
大体时间:at the initiation of NPPV
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at the initiation of NPPV
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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
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During hospitalization period (after recruitment into the study)
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Deterioration Vital Signs
大体时间:during the first 24 hours of the study
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during the first 24 hours of the study
|
|
Deterioration in Gas Exchange
大体时间:during the first 24 hours of the study
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during the first 24 hours of the study
|
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Total Length of Time Requiring NIV
大体时间:during hospitalization (after recruitment)
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during hospitalization (after recruitment)
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Length of Hospital Stay
大体时间:during hospitalization (after recruitment)
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during hospitalization (after recruitment)
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In-hospital Mortality Rate
大体时间:during hospitalization (after recruitment)
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during hospitalization (after recruitment)
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合作者和调查者
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB-6060
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