Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of oxyhemoglobin desaturation episodes
研究概览
简要总结
Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath.
The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.
To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria.
If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device.
Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.
详细描述
Acquired Brain Injury (ABI) is one of the most frequent cause of death and disability worldwide. Swallowing disorders and cough insufficiency followed by pulmonary infections and a bad secretions management are some of the associated complications. When a tracheal cannula is applied, the patient conditions could get worse. Unfortunately ABI patients often can't properly collaborate to the treatment/assessment processes due to their consciousness disorders. According to all these reasons, ABI patients need a multi-professional assistance focused on swallowing and respiratory rehabilitative treatments to improve their health conditions.
Free Aspire device with Expiratory Flow Accelerator (EFA) technology, thanks to the expiratory flow acceleration, allows to remove tracheobronchial secretions and an improvement of the swallowing ability.
EFA, compared to other devices, is simple to use and does not require the active collaboration of the patient. Indeed, the purpose of the study is to investigate its effects on secretion management ability and to evaluate if EFA can reduce the frequency of Hospital Acquired Pneumonia (HAP). In addition, the study evaluates the effectiveness of EFA in accelerating tracheotomy weaning.
Patients will be recruited following accurate inclusion/exclusion criteria at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.
At baseline assessment (1 week), the following parameters will be assessed daily for each patient recruited:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age higher than 18 years old;
- •Hospitalization after diagnosis of Acquired Brain Injury (both traumatic and vascular)
- •Levels of Cognitive Functioning Scale (LCFS) score between 1and 5;
- •Presence of spontaneous breathing, at least during the day
排除标准
- •Need of mechanical ventilation for more than 12 hours a day;
- •Presence of tracheal stoma not properly healed after the removal of the tracheal cannula.
结局指标
主要结局
Change of oxyhemoglobin desaturation episodes
时间窗: During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered
Change in the the frequency of oxyhemoglobin desaturation episodes.
次要结局
- Reduction of tracheal cannula aspiration(During the data collection in the 8 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.)
- Number of patient that develop hospital-acquired pneumonia(During the data collection in the 8 weeks of treatment for each patient, the number of hospital-acquired pneumonia that require an antibiotic treatment will be registered)
- Staff satisfaction(From baseline to last observation (at the of 8 weeks treatment))
- Change of tracheostomy weaning time(From baseline to last observation (at the of 8 weeks treatment))