Pilot Study of the Cough Reflex Assessment in Patients With Tracheostomy Cannula Following Severe Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PCEF of the reflex cough
研究概览
简要总结
The cough assessment is fundamental in the weaning process as it gives information on the possibility to expel food and secretion out from the airways. The majority of persons suffering from severe acquired brain injury are not able to cough voluntary due to severe cognitive deficit. In the present study, it would be evaluated the intensity of the reflex cough (RC) and the results would be correlated with weaning outcome.
详细描述
All the participants will undergo firstly to the RC assessment. RC would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali). The face mask would be connected with the spirometer and the nebulizer via a bidirectional valve in order to measure Peak of Cough Expiratory Flow (PCEF) of the RC. Secondly, it would be assessed parameters of the weaning protocol in order to verify the feasible of removing the tracheostomy cannula. Hence, if the previous assessments are positive, the cannula 's patients would be removed. The follow-up would be taken after 96 hours from the decannulation in order to verify the outcome of weaning.
In this study, it would be recruited a number of 30 consecutive patients admitted to IRCCS Ospedale San Camillo. The data would be firstly analyzed using Kolmogorov-Smirnov test in order to verify the distribution. Secondly it would be chosen to t-test for parametric outcomes or Wilcoxon non parametric outcomes. Thirdly, the correlation between the Peak of Cough Expiratory Flow of the RC and the weaning outcome would be completed using Pearson Test (parametric) or Spearman test (non parametric).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Acquired Brain Injury
- •presence of tracheostomy cannula and positive cupping trial
- •provide informed consent independently
排除标准
- •presence of allergy to citrus;
- •presence of asthma
- •presence of mechanical ventilation;
- •presence of trachomalacia
- •presence of laryngeal stenosis
结局指标
主要结局
PCEF of the reflex cough
时间窗: 8 weeks
Peak of expiratory flow during reflex cough in patients with severe acquired brain injury
次要结局
- PCEF of the reflex cough after decannulation(9 weeks)
研究者
Irene Battel
Speech and Language Therapist
IRCCS San Camillo, Venezia, Italy