Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques in Non-hospitalized Infants With Acute Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Wang clinical severity scale
研究概览
简要总结
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF) appears as a treatment measure complementary in the clinical guidelines and consensus on the management of the BQ.
详细描述
Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator.
The assignment will be made at the time of query according to a table of random numbers previously established and that it will only be known by physiotherapists.
Before starting the treatment protocol, a blind evaluator who does not know the treatment to which the patient is assigned, classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter measuring cup, once the respiratory physiotherapy session is finished, it will be done in a calibrated weight in both groups.
The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged slow expiration and coughing provoked. Is apassive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.
The protocol in the high frequency compression chest wall group consists of the same protocol as the respiratory physiotherapy Group plus high frequency compression chest wall applied with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.
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
- None
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following inclusion criteria:
- •Have an age between 2 months and 12 months.
- •Have a medical diagnosis of the first episode of BQ.
- •Have the informed consent signed by the child's legal guardians.
排除标准
- •The criteria of exclusion are:
- •BQ in acute phase with score> 9 according to Wang clinical scale.
- •Associated cardiac, neurological or traumatic pathology.
- •Previous hospitalization for wheezing.
- •Medical diagnosis of recurrent sibilant.
结局指标
主要结局
Wang clinical severity scale
时间窗: 12 weeks
The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.
次要结局
- Oxygen saturation(12 weeks)
- Heart rate(12 weeks)
- Amount of sputum(12 weeks)
研究者
J. Nicolas Cuenca Zaldivar
Rehabilitation Service Principal Investigator
Guadarrama Hospital