Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Respiratory difficulty
研究概览
简要总结
The accumulation of secretions in the bronchopulmonary air network promotes the detriment of respiratory functions generating hypoxia and causing a decrease in the cardiac output requiring the use of mechanical ventilation and hemodynamic support. It is intended to control the accumulation of secretions by means of Respiratory Pediatric Physiotherapy (RPP) and to evaluate its effectiveness counting on biological plausibility.
详细描述
The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to postural drainage plus compression to the muscle belly of the upper limbs, as an adjuvant treatment for children with pneumonia. It is expected that the clinical severity decreases by 1.5 in the Wang score (a modification of the Silverman score), with a standard deviation of 2.6 points and a decrease of two days in the hospital stay with a α 0.05 in a one-tail test, a P of 80% and a 95.5% confidence interval.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
- A sequence of aleatory numbers in blocks of 2 will be generated in each of the study groups using the software randomization.com, done by a person foreign to the research.
- Using the randomized numbers generated by the software, it will be decided what group each participant belongs to (control or intervention) and what maneuver will be assigned to them.
- These numbers and their maneuvers will be placed inside dark envelopes.
- The whole randomization and assignment sequence will be performed by a person foreign to the research and without the knowledge of the researchers. Support will be provided from the coordination for nursing research, who will select the personnel for the process.
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the Hospital Infantil de México Federico Góme with diagnosis of pneumonia (considering the diagnostic criteria of the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department.
- •Patients aged 0 to 8 years old.
- •A minimum HS of 72 hours.
- •Having informed consent.
- •Not having had previous RPP treatment.
排除标准
- •Presenting a fever state for more than three days. Performing physiotherapy increases the body's peripheral temperature.
- •Presenting an oxygen saturation below 80%.
- •Requiring mechanical ventilation.
- •Hemodynamic instability.
- •Presenting systemic inflammatory response syndrome.
- •Inotropic support.
- •Anatomical variants in the thorax.
- •Unstable thorax.
- •Esophageal atresia.
- •Pleural effusion, pneumothorax.
- •Alterations that compromise respiratory centers and/or the phrenic nerve.
- •Neuromuscular diseases that compromise respiratory mechanics.
结局指标
主要结局
Respiratory difficulty
时间窗: 5 days
The Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty.
次要结局
- Hospital stay(7 days)
研究者
Adrian Morales Muñoz
Principal Investigator
Hospital Infantil de Mexico Federico Gomez