Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Efficiency of PEEP level on speech
研究概览
简要总结
Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients.
The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. The best level for speech may vary from one patient to the other The purpose of this study is to determine individually the most efficient PEEP level in terms of speech while obtaining the most secure condition and the best possible respiratory tolerance. In order to improve the latter, the investigators will use a device which allows the patients to control the activation of PEEP so that they can use it only when needed (i.e. when they wish to speak). The investigators will compare the effect of different PEEP level to try to determine the best compromise to improve speech in tracheostomized ventilator-dependent patients.
详细描述
Context :
Allowing a functional communication is a major issue in order to preserve quality of life in tracheostomized ventilator-dependent patients.
We showed in a previous study that the use of a positive end-expiratory pressure (PEEP) in neuromuscular tracheostomized ventilator-dependent patients improved speech as it allows the patient to expire (at least partly) through the upper airways therefore to speak during expiration. The use of PEEP has been compared to the use of a phonation valve placed on the ventilator circuit which allows a complete expiration through the upper airways and therefore speech. Both techniques seem similar in terms of efficiency on speech; PEEP, however, is better tolerated and seems to be more secure (the system remains open during expiration decreasing the risk of high pressure, it does not require any handling of the ventilator circuit).
Optimal PEEP level allowing the patient to expire the total expiratory volume through the upper airways PEEPeff may vary from one patient to the other. We seek to determine individual PEEPeff and to compare it to 50% of its value (PEEPef50). Indeed, while PEEPeff may constitute the best level for expiratory speech as it mimics the mechanisms of a phonation valve without some of its fallbacks, by preventing expiration through the expiratory circuit of the ventilator, it also may lengthen expiration, delaying inspiration which allows speech, and facilitate hyperinflation leading to respiratory discomfort as we have previously observed with some patients using a phonation valve. Optimal PEEP level would be the best compromise between best possible phonation and best possible respiratory comfort and therefore could be lower than PEEPeff.
In order to improve respiratory comfort with higher PEEP level, we developed a prototype ventilator in which PEEP is activated by a switch under the control of patients who may activate it only when needed (during speech period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Stable state upon inclusion
- •Neuromuscular patients, tracheostomized and on long term ventilation with a cuffless tube
- •Assist control volumetric ventilation mode
- •Signed consent form
排除标准
- •Pregnancy
- •Patients unable to read
- •Acute respiratory failure
- •Contra-indication of PEEP use
- •Lack of social security coverage
结局指标
主要结局
Efficiency of PEEP level on speech
时间窗: 20 minutes
Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle.
次要结局
- Respiratory tolerance(20 minute)
- Use of PEEP control switch(20 minutes)
- Respiratory Comfort evaluated with a visual analogic scale by patients(20 minutes)
- Effect of PEEP level on voice quality(20 minutes)
研究者
PRIGENT
Dr Helene PRIGENT MD
University of Versailles