Safety of Airway Clearance Combined With Bronchodilator and Hypertonic Saline 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
- 265
- 试验地点
- 2
- 主要终点
- Wang clinical severity scale
研究概览
简要总结
Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not require hospitalization. The technique of prolonged slow expiration followed by cough caused in children not hospitalized with mild and moderate bronchiolitis can improve clinical severity
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.
Before starting the treatment protocol, a blind evaluator treats the was assigned the patient classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and heart rate measured through a pulse oximeter.
The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
Care must be taken during the maneuvers of maintaining a position of the infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting.
They are considered as criteria of cessation of the physiotherapeutic intervention, alterations abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or hypertonia and changes in skin color (pallor or cyanosis). In addition to these clinical manifestations, it establishes that if the father or legal guardian demands it, the application of the protocol would be terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 medical diagnosis of first episode of BQ of maximum 48 hours of evolution.
- •Not previously received respiratory physiotherapy since its diagnosis.
- •Have the informed consent signed by the child's legal guardians.
排除标准
- •The exclusion criteria are:
- •Acute BQ with score> 9 according to the Wang clinical scale.
- •Pathology associated cardiac, neurological or traumatic.
- •Previous hospitalizations 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)
研究者
J. Nicolas Cuenca Zaldivar
Rehabilitation Service Principal Investigator
Guadarrama Hospital