Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- Tidal volume
研究概览
简要总结
Respiratory diseases are a major morbidity and mortality causes of neonatal requiring mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy becomes increasingly necessary in order to minimize the effects of complications and improve respiratory functions, increasing mucociliary transport with techniques that consist of manual maneuvers to bronchial hygiene, such as vibro associated with postural drainage and prolonged slow exhalation. Objective: To compare and analyze the effects of convensional physiotherapy (CP) versus prolonged slow exhalation (PSE) in heart rate (HR), and respiratory rate (RR), O2 saturation (SpO2) and Tidal Volume (TV), time permanence of mechanical ventilation (TMV) and number of extubation failure (EF) in premature infants on mechanical ventilation (MV). Methods: Randomized clinical trial conducted in the neonatal intensive care unit of the General Hospital Itapecerica da Serra Seconci OSS SP, comparing two physical therapy techniques applied to preterm infants on mechanical ventilation.
详细描述
Neonates patients admitted at unit of Intensive Care of Geral Hospital of Itapecerica da Serra (São Paulo-Brazil) will recruited to this study. Based on World Health Organization (WHO), the neonates preterm are those who present gestational age (GA) <35 weeks (gestational age was calculated based on the date of last menstruation). Inclusion criteria: neonates born at GA<35 weeks, under mechanical ventilation (interplus 5 -Intermédica® or servo i (Maquet, Solvan, Sweden) for the first 7 days of life, hemodynamically stable; birth weight ≤1.500 gram; per cent change inspired oxygen received (FiO2) ≤ 0.6; Inspiratory pressure ≥ 25 cmH2O; medical prescription of chest physiotherapy. Exclusion criteria: congenital malformation graves; genetic syndromes and situations, pulmonary hypertension, peri-intraventricular hemorrhage and coagulopathies.
All patients will receive chest physiotherapy when it is necessary and all of them will monitored until dischange.
After performed all included criteria, patients will randomized in 2 groups: group CCP (patients submitted to conventional chest physiotherapy techniques) or group PSE (patients submitted to prolonged slow exhalation technique).
After that, for both group, physiotherapist take note of gestacional age, gender, bith weight (gram), Apgar score (1º; 5º and 10º minute), type of delivery, medical diagnosis, mechanical ventilation parameters, medications. Then, lung auscultation, breathing pattern, pulse oximetry and radiological chest pattern of all patients will evaluated by the same physiotherapist.
CCP group (n=22): patients will submitted to a postural drainage associated with manual vibration. They will positionated with left or right of ribcage to up and then physiotherapist made a manual vibratory movements associated with a mild compression in ribcage at the end of expiratory phase. The technique was made during 5 minutes in each side. After that, endotraqueal aspiration will performed.
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 (Participant)
入排标准
- 年龄范围
- 30 Weeks 至 34 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterms born at gestational age <35 weeks under mechanical ventilation
排除标准
- •congenital malformation graves;
- •genetic syndromes,
- •pulmonary hypertension,
- •peri-intraventricular haemorrhage and coagulopathies.
研究组 & 干预措施
Conventional Physiotherapy (PT)
Postural drainage + manual vibration
干预措施: Conventional Physiotherapy (Other)
Prolonged slow exhalation technique
Prolonged exhalation + Conventional PT
干预措施: Prolonged slow exhalation technique (Other)
结局指标
主要结局
Tidal volume
时间窗: 10 minutes twice a day
Measured by the mechanical ventilator
次要结局
- Respiratory rate(10 minutes twice a day)
研究者
Viviani Barnabe
Dr
Universidade Cidade de Sao Paulo
